Explore the broad array of multiple myeloma clinical trials

DARZALEX® in newly diagnosed multiple myeloma
DARZALEX® in relapsed or refractory multiple myeloma
DARZALEX FASPRO® in newly diagnosed multiple myeloma
DARZALEX FASPRO® in relapsed or refractory multiple myeloma

DARZALEX® in newly diagnosed multiple myeloma

For newly diagnosed, transplant-ineligible multiple myeloma, ALCYONE trial studied the addition of DARZALEX® to VMP regimen1

A large, randomized, open-label, multicenter, active-controlled phase 3 trial of DARZALEX® + VMP vs VMP alone1,2
Alcyone Study DesignAlcyone Study Design
  • Patients in the DARZALEX® + VMP arm received DARZALEX® 16 mg/kg until disease progression or unacceptable toxicity1
  • Participants received bortezomib 1.3 mg/m2 as subcutaneous injection, twice weekly at Weeks 1, 2, 4, and 5 (Cycle 1) followed by once weekly at Weeks 1, 2, 4, and 5 (Cycles 2-9); melphalan 9 mg/m2 and prednisone 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9). Per protocol, VMP treatment was discontinued in both arms after 9 cycles1*
  • Primary endpoint was efficacy evaluated by progression-free survival (PFS) based on International Myeloma Working Group (IMWG) criteria2
  • Key secondary endpoints included overall response rate (ORR), rates of very good partial response (VGPR) or better, complete response (CR) or better, negative status for minimal residual disease (MRD), and overall survival (OS)2
  • Additional endpoints included time to response, duration of response, safety, and side effect profile2
DVMP=DARZALEX® (D) + bortezomib (V) + melphalan (M) + prednisone (P); ECOG=Eastern Cooperative Oncology Group; SCT=stem cell transplant; VMP=bortezomib (V) + melphalan (M) + prednisone (P).
*Prednisone was withheld on Day 1 of each cycle when dexamethasone was used as premedication to reduce the risk of infusion reactions.2
Patient characteristics: baseline demographics were similar between arms1,2
Alcyone Patient CharacteristicAlcyone Patient Characteristic
ECOG=Eastern Cooperative Oncology Group; VMP=bortezomib (V) + melphalan (M) + prednisone (P).
National Comprehensive Cancer Network® (NCCN®) Category 1, other recommended
Daratumumab* (D) in combination with bortezomib (V), melphalan (M), and prednisone (P) is recommended by the NCCN Guidelines as a Category 1, other recommended therapeutic option for patients with newly diagnosed, transplant-ineligible multiple myeloma
*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.
See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

DARZALEX® + VMP demonstrated proven efficacy vs VMP alone1
Alcyone PFS DesktopAlcyone PFS Mobile
CI=confidence interval; DVMP=DARZALEX® (D) + bortezomib (V) + melphalan (M) + prednisone (P); HR=hazard ratio; mPFS=median progression-free survival; PFS=progression-free survival; VMP= bortezomib (V) + melphalan (M) + prednisone (P).
Median PFS in the DARZALEX® + VMP regimen had not been reached vs 18.1 months
with VMP alone1
DARZALEX® + VMP significantly improved OS vs VMP alone (P=0.0003)1
Alcyone OS DesktopAlcyone OS mobile
CI=confidence interval; DVMP=DARZALEX® (D) + bortezomib (V) + melphalan (M) + prednisone (P); HR=hazard ratio; OS=overall survival; VMP= bortezomib (V) + melphalan (M) + prednisone (P).
Median OS was not reached for either arm1
Significant improvement in ORR with DARZALEX® + VMP1
Almost all patients (91%) treated with DARZALEX® + VMP demonstrated a clinical response.1
Alcyone ORR DesktopAlcyone ORR Mobile
CR=complete response; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; VMP=bortezomib (V) + melphalan (M) + prednisone (P).
Speed of response
  • In responders, median time to response was 0.79 months (range: 0.4-15.5 months) in the DARZALEX® + VMP group and 0.82 months (range: 0.7-12.6 months) in the VMP group1
Depth of response
  • 42.6% of patients achieved CR or better with DARZALEX® + VMP vs 24.4% with VMP alone1
Duration of response
  • Median duration of response had not yet been reached with DARZALEX® + VMP vs 21.3 months (range: 0.5+, 23.7+) with VMP alone1
Significantly higher MRD negativity rate with DARZALEX® + VMP1
3.6x higher MRD negativity rate with DARZALEX® + VMP vs VMP alone (P<0.0001).
DVMP negative rate
DARZALEX® + VMP
(n=78)
(95% CI: 18.0, 27.0)
VS
VMP negative rate
with VMP alone
(n=22)
(95% CI: 3.9, 9.2)
  • Minimal residual disease (MRD) based on threshold of 10-5 using a next-generation sequencing assay
  • In patients with CR or better, the MRD negativity rate was 49.7% (n=74) (95% CI: 41.4, 58.0) in the DARZALEX® + VMP arm vs 25.3% (n=22) (95% CI: 16.6, 35.7) with VMP arm

DARZALEX® + VMP safety profile
Adverse reactions with incidence ≥10%1
Alcyone Adverse DesktopAlcyone Adverse Mobile
VMP=bortezomib (V) + melphalan (M) + prednisone (P).
aUpper respiratory tract infection, bronchitis, bronchitis bacterial, epiglottitis, laryngitis, laryngitis bacterial, metapneumovirus infection, nasopharyngitis, oropharyngeal candidiasis, pharyngitis, pharyngitis streptococcal, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, viral pharyngitis, viral rhinitis, viral upper respiratory tract infection.
bInfusion-related reaction includes terms determined by investigators to be related to infusion.
cEdema peripheral, generalized edema, peripheral swelling.
dPneumonia, lung infection, pneumonia aspiration, pneumonia bacterial, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, and pulmonary sepsis.
eCough, productive cough.
fDyspnea, dyspnea exertional.
gHypertension, blood pressure increased.
Note: Adverse reactions that occurred in ≥10% of patients and with at least 5% greater frequency in the DARZALEX® + VMP arm are listed.1
  • The most frequent adverse reactions (≥20% with at least 5% greater frequency in the DVMP arm) were infusion reactions, upper respiratory tract infection, and peripheral edema1
    • Serious adverse reactions with at least a 2% greater incidence in the DARZALEX® + VMP arm compared with the VMP arm were pneumonia (DVMP 11% vs VMP 4%), upper respiratory tract infection (DVMP 5% vs VMP 1%), and pulmonary edema (DVMP 2% vs VMP 0%)1
Treatment-emergent hematology laboratory abnormalities1
Alcyone Lab DesktopAlcyone Lab Mobile
VMP=bortezomib (V) + melphalan (M) + prednisone (P).
  • Grade 3 or 4 infections were 23% with DARZALEX® + VMP vs 15% with VMP alone2
Discontinuation rates due to adverse reactions with DARZALEX® combination therapy in newly diagnosed, transplant-ineligible patients with multiple myeloma2
Alcyone Safety Desktop
DARZALEX® + VMP
VS
Alcyone safety_3 Desktop
with VMP alone
Frequency of IRRs (any grade) across clinical trials (N=2066)1
37%
of patients had IRRs with the Week 1 infusion
2%
of patients had IRRs with the Week 2 infusion
6%
of patients had IRRs with subsequent infusions
IRRs=infusion-related reactions.
Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs
For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1
Alcyone irris DesktopAlcyone irris Mobile
IRR=infusion-related reaction.
Interference with serological testing1
DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.
Reminders
  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®
Brochure on daratumumab and serological testing
Identification card to give to patients taking daratumumab

For newly diagnosed, transplant-eligible multiple myeloma, CASSIOPEIA trial demonstrated significance of adding DARZALEX® to VTd regimen1

Phase 3 study comparing DARZALEX® + VTd vs VTd alone for induction and consolidation treatment1,3
Cassiopeia Study DesignCassiopeia Study Design
  • In an ongoing part 2 of the study, patients underwent a second randomization in both treatment groups to either observation or DARZALEX® Q8W monotherapy for maintenance. The efficacy and safety of this maintenance regimen is currently being evaluated3
  • DARZALEX® dosing and administration: IV, 16 mg/kg actual body weight QW Cycles 1–2 and Q2W Cycles 3–4 (induction phase); Q2W Cycles 5–6 (consolidation phase)1
  • VTd dosing and administration: Bortezomib (V) SC or IV, 1.3 mg/m2 BSA twice weekly for 2 weeks on Days 1, 4, 8, and 11 of repeated 28-day (4-week) induction cycles (Cycles 1–4) and 2 consolidation cycles (Cycles 5–6); thalidomide (T) PO, 100 mg daily during the 6 bortezomib cycles; dexamethasone (d) PO or IV, 40 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23 of Cycles 1 and 2, and at 40 mg on Days 1–2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16) of Cycles 3–4. Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, and 16 in Cycles 5–6. On the days of DARZALEX® infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication1
  • Primary endpoint was stringent complete response (sCR) rate at Day 100 post-transplant3
  • Key secondary endpoints included: rate of CR or better, PFS from first randomization and OS from first randomization3
  • Patient characteristics: the median age was 58 years; 59% male; 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1, and 10% had an ECOG performance score of 2; 40% had ISS Stage I, 45% had ISS Stage II, and 15% had ISS Stage III disease1
  • Approval of frontline treatment of transplant-eligible patients with multiple myeloma is based on the response evaluation of Part 1 only of this trial at Day 100 post-transplant
BSA=body surface area; CR=complete response; DVTd=DARZALEX® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System; IV=intravenous; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PO=by mouth; PR=partial response; QW=weekly; Q2W=every 2 weeks; Q8W=every 8 weeks; SC=subcutaneous; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
National Comprehensive Cancer Network® (NCCN®) Category 2A, useful in certain circumstances
Daratumumab* (D) in combination with bortezomib (V), thalidomide (T) and dexamethasone (d) is recommended by the NCCN Guidelines as a Category 2A, useful in certain circumstances therapeutic option for newly diagnosed, transplant-eligible multiple myeloma
*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.
See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Adding DARZALEX® to VTd resulted in significantly more patients with sCR vs VTd alone after consolidation1,3
Cassiopeia SCRCassiopeia SCR
DARZALEX® + VTd post-consolidation responses1,3
Cassiopeia Efficacy
CR or better with DARZALEX® + VTd vs 26% for VTd alone (P<0.0001)
Cassiopeia Efficacy
VGPR or better with DARZALEX® + VTd vs 78% for VTd alone
Cassiopeia Efficacy
ORR with DARZALEX® + VTd vs 90% with VTd alone
  • Response rates for DARZALEX® + VTd vs VTd alone were, respectively: sCR, 28.9% vs 20.3%; CR, 9.9% vs 5.7%; VGPR, 44.6% vs 52.0%; PR, 9.2% vs 11.8%
CR=complete response; ITT=intent-to-treat; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
53% reduction in the risk of disease progression or death with DARZALEX® + VTd vs VTd alone1*
Cassiopeia PfsCassiopeia Pfs
*Based on interim analysis and the boundary for PFS was crossed.
~90% of patients in each treatment arm underwent ASCT3
  • 489 (90%) with DARZALEX® + VTd and 484 (89%) with VTd alone3
  • 85% of patients in the DARZALEX® + VTd group and 81% of those in the VTd group completed all 4 induction and both consolidation cycles at 18.8 months (median follow-up)1,3
ASCT=autologous stem cell transplant; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

DARZALEX® + VTd safety profile for induction and consolidation treatment1
Most frequent adverse reactions and laboratory abnormalities reported in ≥20% of patients and with at least a 5% greater frequency in the DARZALEX® + VTd arm.1*
Cassiopeia Adverse ReactionsCassiopeia Adverse Reactions
aInfusion-related reaction includes terms determined by investigators to be related to infusion.
bLaryngitis, laryngitis viral, metapneumovirus infection, nasopharyngitis, oropharyngeal candidiasis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinovirus infection, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection, viral pharyngitis, viral rhinitis, viral upper respiratory tract infection.
cBronchiolitis, bronchitis, bronchitis chronic, respiratory syncytial virus bronchitis, tracheobronchitis.
Cassiopeia Lab AbnormalitiesCassiopeia Lab Abnormalities
*Adverse reactions that occurred with a frequency of ≥10% and <20%, and with at least a 5% greater frequency in the DARZALEX® + VTd arm were cough, vomiting, and hypertension.1
Serious adverse reactions with a 2% greater incidence in the DVTd arm compared with the VTd arm were bronchitis (DVTd 2% vs VTd <1%) and pneumonia (DVTd 6% vs VTd 4%).1
  • Discontinuation rates due to any adverse event: 7% with DVTd vs 8% with VTd3
  • Infusion reactions with DVTd occurred in 35% of patients; 3% were Grade 3 and <1% were Grade 41
  • Most infusion reactions occurred during the first infusion3
Frequency of infusion reactions (any grade) in the clinical trial (n=536)3
Pre-transplant
Cassiopeia Safety
of patients had IRs with the first infusion
Cassiopeia Safety
of patients had IRs with the second infusion
Post-transplant
Cassiopeia Safety
of patients had IRs with the first post-transplant infusion
IRs=infusion reactions.
Overall, 12% of patients had infusion reactions with subsequent infusions.3
  • Administer pre-infusion and post-infusion medications to reduce the risk of infusion reactions [see section 2.3 of the DARZALEX® full Prescribing Information]1
DVTd=DARZALEX® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
Frequency of IRRs (any grade) across clinical trials (N=2066)1
37%
of patients had IRRs with the Week 1 infusion
2%
of patients had IRRs with the Week 2 infusion
6%
of patients had IRRs with subsequent infusions
IRRs=infusion-related reactions.
Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs
For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1
Alcyone irris DesktopCassiopeia Safety Irrs Table
IRR=infusion-related reaction.
Interference with serological testing1
DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.
Reminders
  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®
Brochure on daratumumab and serological testing
Identification card to give to patients taking daratumumab

DARZALEX® in relapsed or refractory multiple myeloma

For relapsed or refractory multiple myeloma, after 1 prior therapy, POLLUX trial compared treatment with DARZALEX® + Rd vs Rd alone1

A multicenter, open-label, active-controlled phase 3 study1,4
  • A majority (86%) of patients received prior treatment with a proteasome inhibitor (PI)1
  • More than half (55%) of patients received prior treatment with an immunomodulatory agent1

Patients were refractory to prior therapies1*

  • 27% to the last line of treatment
  • 18% to a PI only
  • 21% to bortezomib

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); IV=intravenous; PD=progressive disease; PO=by mouth; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks; Rd=lenalidomide (R) + dexamethasone (d).

*Please note that this is not a full list of prior therapies reported at baseline and that lenalidomide-refractory patients were excluded from the study.4

Patient characteristics: baseline demographics were similar between arms1,4

ECOG=Eastern Cooperative Oncology Group; Rd=lenalidomide (R) + dexamethasone (d).

The primary endpoint was progression-free survival (PFS) and the median follow-up
was 13.5 months1,4

Efficacy was evaluated by PFS based on International Myeloma Working Group (IMWG) criteria.1

National Comprehensive Cancer Network® (NCCN®) Category 1, preferred

Daratumumab* (D) in combination with lenalidomide (R) and dexamethasone (d) is recommended by the NCCN Guidelines as a Category 1 preferred therapeutic option for patients with relapsed or refractory multiple myeloma

*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

DARZALEX® + Rd demonstrated superior efficacy vs Rd alone1

CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; mPFS=median progression-free survival; PFS=progression-free survival; Rd=lenalidomide (R) + dexamethasone (d).

At a median follow-up of 13.5 months, median PFS was not reached with DARZALEX® + Rd triplet therapy vs 18.4 months with Rd1

Complete response rate more than doubled with DARZALEX® + Rd1

Almost all (91%) patients responded to DARZALEX® + Rd.

CR=complete response; ORR=overall response rate; PR=partial response; Rd=lenalidomide (R) + dexamethasone (d); sCR=stringent complete response; VGPR=very good partial response.

Deeper and sustained responses were demonstrated with DARZALEX® + Rd vs Rd1

With DARZALEX® + Rd, median time to first response was 1 month (range: 0.9 to 13 months).

Median duration of response was not yet reached with DARZALEX® + Rd (range: 1+ to 19.8+ months) vs 17.4 months with Rd (range: 1.4 to 18.5+ months), at a median follow-up of 13.5 months1

DARZALEX® + Rd safety profile
Adverse reactions with incidence ≥10%1

Rd=lenalidomide (R) + dexamethasone (d).

aUpper respiratory tract infection, bronchitis, sinusitis, respiratory tract infection viral, rhinitis, pharyngitis, respiratory tract infection, metapneumovirus infection, tracheobronchitis, viral upper respiratory tract infection, laryngitis, respiratory syncytial virus infection, staphylococcal pharyngitis, tonsillitis, viral pharyngitis, acute sinusitis, nasopharyngitis, bronchiolitis, bronchitis viral, pharyngitis streptococcal, tracheitis, upper respiratory tract infection bacterial, bronchitis bacterial, epiglottitis, laryngitis viral, oropharyngeal candidiasis, respiratory moniliasis, viral rhinitis, acute tonsillitis, rhinovirus infection.

bInfusion-related reaction includes terms determined by investigators to be related to infusion.

cCough, productive cough, allergic cough.

dDyspnea, dyspnea exertional.

Note: Adverse reactions that occurred in >10% of patients and with at least 5% greater frequency in the DARZALEX® + Rd arm are listed.

  • Infusion reaction includes terms determined by investigators to be related to infusion. Severe infusion reactions included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision1
  • The most frequent adverse reactions (≥20%) with DARZALEX® + Rd (DRd) were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasms, cough, and dyspnea1
  • Serious adverse reactions with at least a 2% greater incidence in the DARZALEX® + Rd arm compared to the Rd arm were pneumonia (DRd 12% vs Rd 10%), upper respiratory tract infection (DRd 7% vs Rd 4%), influenza and pyrexia (DRd 3% vs Rd 1% for each)1
Treatment-emergent hematology laboratory abnormalities1

Rd=lenalidomide (R) + dexamethasone (d).

  • Grade 3/4 infections between study arms: 28% vs 23% with DARZALEX® + Rd and Rd, respectively4
  • Discontinuation rates due to adverse reactions with DARZALEX® + Rd were similar to Rd alone (7% vs 8%, respectively)1
Frequency of IRRs (any grade) across clinical trials (N=2066)1

37%

of patients had IRRs with the Week 1 infusion

2%

of patients had IRRs with the Week 2 infusion

6%

of patients had IRRs with subsequent infusions

IRRs=infusion-related reactions.

Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs

For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1

IRR=infusion-related reaction.

Interference with serological testing1

DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.

Reminders

  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®

Brochure on daratumumab and serological testing

Download brochure

Identification card to give to patients taking daratumumab

Download ID card

For relapsed or refractory multiple myeloma, after 1 prior therapy, CASTOR trial compared treatment with DARZALEX® + Vd vs Vd alone1

A multicenter, open-label, active-controlled, phase 3 study1,5

DVd=DARZALEX® (D) + bortezomib (V) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; Vd=bortezomib (V) + dexamethasone (d).

  • A majority (76%) of patients received prior treatment with an immunomodulatory agent1
  • More than half (69%) of patients received prior treatment with a proteasome inhibitor (PI)1

Patients were refractory to prior therapies1*

  • 32% to the last line of treatment
  • 33% to an immunomodulatory agent only
    • 24% in the DARZALEX® + Vd arm and 33% in the Vd arm to lenalidomide

Vd=bortezomib (V) + dexamethasone (d).

*Please note that this is not a full list of prior therapies reported at baseline and that bortezomib-refractory patients were excluded from the study.

Patient characteristics: baseline demographics were similar between arms1

ECOG=Eastern Cooperative Oncology Group; Vd=bortezomib (V) + dexamethasone (d).

The primary endpoint was progression-free survival (PFS) and the median follow-up
was 7.4 months1,5

Efficacy was evaluated by PFS based on International Myeloma Working Group (IMWG) criteria.1

National Comprehensive Cancer Network® (NCCN®) Category 1, preferred

Daratumumab* (D) in combination with bortezomib (V) and dexamethasone (d) is recommended by the NCCN Guidelines as a Category 1 preferred therapeutic option for patients with relapsed or refractory multiple myeloma

*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

DARZALEX® + Vd demonstrated superior efficacy vs Vd alone1

CI=confidence interval; DVd=DARZALEX® (D) + bortezomib (V) + dexamethasone (d); HR=hazard ratio; PFS=progression-free survival; Vd=bortezomib (V) + dexamethasone (d).

Median PFS had not yet been reached with DARZALEX® + Vd triplet therapy vs 7.2 months with Vd1

Complete response rate more than doubled with DARZALEX® + Vd1

The majority (79%) of patients responded to DARZALEX® + Vd.

CR=complete response; ORR=overall response rate; PR=partial response; sCR=stringent complete response; Vd=bortezomib (V) + dexamethasone (d); VGPR=very good partial response.

Deeper and sustained responses were demonstrated with DARZALEX® + Vd vs Vd1

With DARZALEX® + Vd, median time to first response was 0.8 months (range: 0.7 to 4 months).

Median duration of response was not yet reached with DARZALEX® + Vd (range: 1.4+ to 14.1+ months) vs 7.9 months with Vd (range: 1.4+ to 12+ months), at a median follow-up of 7.4 months1

Established safety profile of DARZALEX® + Vd
Adverse reactions with incidence ≥10%1

Vd=bortezomib (V) + dexamethasone (d).

aInfusion-related reaction includes terms determined by investigators to be related to infusion.

bUpper respiratory tract infection, bronchitis, sinusitis, respiratory tract infection viral, rhinitis, pharyngitis, respiratory tract infection, metapneumovirus infection, tracheobronchitis, viral upper respiratory tract infection, laryngitis, respiratory syncytial virus infection, staphylococcal pharyngitis, tonsillitis, viral pharyngitis, acute sinusitis, nasopharyngitis, bronchiolitis, bronchitis viral, pharyngitis streptococcal, tracheitis, upper respiratory tract infection bacterial, bronchitis bacterial, epiglottitis, laryngitis viral, oropharyngeal candidiasis, respiratory moniliasis, viral rhinitis, acute tonsillitis, rhinovirus infection.

cCough, productive cough, allergic cough.

dEdema peripheral, edema, generalized edema, peripheral swelling.

eDyspnea, dyspnea exertional.

Note: Adverse reactions that occurred in >10% of patients and with at least 5% greater frequency in the DARZALEX® + Vd arm are listed.

  • Infusion reaction includes terms determined by investigators to be related to infusion. Severe infusion reactions included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision1
  • The most frequent adverse reactions (>20%) with DARZALEX® + Vd (DVd) were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea1
  • Serious adverse reactions with at least a 2% greater incidence in the DVd arm compared to the Vd arm were upper respiratory tract infection (DVd 5% vs Vd 2%), diarrhea, and atrial fibrillation (DVd 2% vs Vd 0% for each)1
Treatment-emergent hematology laboratory abnormalities1

Vd=bortezomib (V) + dexamethasone (d).

  • Grade 3/4 infections were similar between study arms: 21% vs 19% with DARZALEX® + Vd and Vd, respectively5
  • Discontinuation rates due to adverse reactions with DARZALEX® + Vd were similar to Vd alone (7% vs 9%, respectively)1
Frequency of IRRs (any grade) across clinical trials (N=2066)1

37%

of patients had IRRs with the Week 1 infusion

2%

of patients had IRRs with the Week 2 infusion

6%

of patients had IRRs with subsequent infusions

IRRs=infusion-related reactions.

Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs

For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1

IRR=infusion-related reaction.

Interference with serological testing1

DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.

Reminders

  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®

Brochure on daratumumab and serological testing

Download brochure

Identification card to give to patients taking daratumumab

Download ID card

For relapsed or refractory multiple myeloma, after 1 to 3 prior therapies, CANDOR and EQUULEUS trials evaluated treatment with DARZALEX® + Kd1

CANDOR: phase 3, randomized, open-label, multicenter study comparing twice weekly DARZALEX® + Kd vs twice weekly Kd alone1,6

ANC=absolute neutrophil count; BIW=twice weekly; DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); IV=intravenous; Kd=carfilzomib (K) + dexamethasone (d); PD=progressive disease; QW=weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.

*For patients aged >75 years on a reduced dexamethasone dose of 20 mg, the entire 20 mg dose was given as pre-medication on days when DARZALEX® was administered.1

Patient characteristics1
  • The median age was 64 years (range: 29–84 years); 58% male; 79% White, 14% Asian, and 2% Black
  • Patients had received a median of 2 prior lines of therapy and 58% of patients had received prior autologous stem cell transplantation (ASCT)
  • 92% received a prior proteasome inhibitor (PI), and of those, 34% were refractory to a PI-including regimen
  • 42% of patients had received prior lenalidomide, and of those, 33% were refractory to a lenalidomide-containing regimen

EQUULEUS: an open-label, multicohort study of once-weekly DARZALEX® + Kd1

EQUULEUS evaluated the efficacy and safety of DARZALEX® in combination with once-weekly carfilzomib (70 mg/m2) and dexamethasone in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.

Baseline patient characteristics (n=85)1

Baseline Characteristics prior

of patients had received prior lenalidomide

Baseline Characteristics prior

of patients were refractory to lenalidomide

Baseline Characteristics prior

of patients were refractory to both a PI and an immunomodulatory agent

PI=proteasome inhibitor.

National Comprehensive Cancer Network® (NCCN®) Category 1, preferred

Daratumumab* (D) in combination with carfilzomib (K) and dexamethasone (d) is recommended by the NCCN Guidelines as a Category 1 preferred therapeutic option for patients with relapsed or refractory multiple myeloma

*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

CANDOR: DARZALEX® + Kd demonstrated superior efficacy vs Kd alone1

CI=confidence interval; DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); HR=hazard ratio; Kd=carfilzomib (K) + dexamethasone (d); PFS=progression-free survival.

PFS was assessed by an independent review committee (IRC) using International Myeloma Working Group (IMWG) response criteria.1

At a median follow-up of 16.9 months and 16.3 months, respectively, the median PFS had not yet been reached for DARZALEX® + Kd vs 15.8 months with Kd alone1,6
Significant improvement in overall response rate (ORR) with DARZALEX® + Kd1

CI=confidence interval; CR=complete response; DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d); ORR=overall response rate; PR=partial response; VGPR=very good partial response.

PFS was assessed by an independent review committee (IRC) using International Myeloma Working Group (IMWG) response criteria.1

*DKd (95% CI: 80, 88).

Kd (95% CI: 67, 81).

Superior minimal residual disease (MRD) negativity with DARZALEX® + Kd vs Kd alone1

CI=confidence interval; CR=complete response; DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d); MRD=minimal residual disease.

Based on a sensitivity threshold of 10-5 using a next-generation sequencing assay (clonoSEQ®). MRD negativity was defined according to the 2016 International Myeloma Working Group Uniform Response Criteria (IMWG-URC).

§DKd (95% CI: 9, 17).

Kd (95% CI: 0.2, 4.6).

P value from the stratified Cochran Mantel-Haenszel Chi-Square test.

EQUULEUS: demonstrated response with once weekly DARZALEX® + Kd1

CI=confidence interval; CR=complete response; Kd=carfilzomib (K) + dexamethasone (d); PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

CANDOR: DARZALEX® + Kd safety profile

Most frequent adverse reactions reported in ≥15% of patients who received DARZALEX® + Kd1

DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d).

aThe incidence of infusion-related reactions is based on a group of symptoms (including hypertension, pyrexia, rash, myalgia, hypotension, blood pressure increased, urticaria, acute kidney injury, bronchospasm, face edema, hypersensitivity, rash, syncope, wheezing, eye pruritus, eyelid edema, renal failure, swelling face) related to infusion reactions, which occurred within 1 day after DKd or Kd administration.

bRespiratory tract infection includes respiratory tract infection, lower respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.

cThrombocytopenia includes platelet count decreased and thrombocytopenia.

dAnemia includes anemia, hematocrit decreased, and hemoglobin decreased.

eFatigue includes fatigue and asthenia.

fAnemia includes anemia, hematocrit decreased, and hemoglobin decreased.

gIncludes fatal adverse reactions.

  • Median treatment duration of 16.1 months (range: 0.1–23.7) with DKd and 9.3 months (range: 0.1–22.4 months) in Kd1
  • Serious adverse reactions occurred in 56% of patients who received DARZALEX® in combination with Kd and 46% of patients who received Kd alone1
  • The most frequent serious adverse reactions reported in the DKd arm as compared with the Kd arm were pneumonia (DKd 14% vs Kd 9%), pyrexia (DKd 4.2% vs Kd 2.0%), influenza (DKd 3.9% vs Kd 1.3%), sepsis (DKd 3.9% vs Kd 1.3%), anemia (DKd 2.3% vs Kd 0.7%), bronchitis (DKd 1.9% vs Kd 0%), and diarrhea (DKd 1.6% vs Kd 0%)1
  • Permanent discontinuation of DARZALEX® due to an adverse reaction occurred in 9% of patients1
  • Fatal adverse reactions within 30 days of the last dose of any study treatment occurred in 10% of 308 patients who received DARZALEX® in combination with Kd vs 5% of 153 patients who received Kd, and the most frequent fatal adverse reaction was infection (4.5% vs 2.6%)1

EQUULEUS: DARZALEX® + Kd safety profile

Most frequent adverse reactions reported in ≥15% of patients receiving DARZALEX® + once weekly carfilzomib and dexamethasone1

DKd=DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d).

aThrombocytopenia includes platelet count decreased and thrombocytopenia.

bFatigue includes fatigue and asthenia.

cThe incidence of infusion-related reactions is based on a group of symptoms (including hypertension, pyrexia, rash, myalgia, hypotension, blood pressure increased, urticaria, acute kidney injury, bronchospasm, face edema, hypersensitivity, rash, syncope, wheezing, eye pruritus, eyelid edema, renal failure, swelling face) related to infusion reactions, which occurred within 1 day after DKd administration.

dRespiratory tract infection includes respiratory tract infection, lower respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.

eAnemia includes anemia, hematocrit decreased, and hemoglobin decreased.

fCough includes productive cough and cough.

gNeutropenia includes neutrophil count decreased and neutropenia.

hLymphopenia includes lymphocyte count decreased and lymphopenia.

  • Median treatment duration of 19.8 months (range: 0.3–34.5 months)1
  • Serious adverse reactions were reported in 48% of patients1
  • The most frequent serious adverse reactions reported were pneumonia (4.7%), upper respiratory tract infection (4.7%), basal cell carcinoma (4.7%), influenza (3.5%), general physical health deterioration (3.5%), and hypercalcemia (3.5%)1
  • Permanent discontinuation of DARZALEX® due to an adverse reaction occurred in 8% of patients1
  • Fatal adverse reactions within 30 days of the last dose of any study treatment occurred in 3.5% of patients who died of general physical health deterioration, multi-organ failure secondary to pulmonary aspergillosis, and disease progression1

DARZALEX® + Kd infusion-related reactions1

  • Infusion-related reactions (IRRs) occurred in 41% of patients; 12% were Grade 3 or 4
  • IRRs of any grade or severity may require management by interruption, modification, and/or discontinuation of the infusion
  • Most IRRs occurred during the first infusion
Frequency of IRRs (any grade) across clinical trials (N=2066)1

37%

of patients had IRRs with the Week 1 infusion

2%

of patients had IRRs with the Week 2 infusion

6%

of patients had IRRs with subsequent infusions

IRRs=infusion-related reactions.

Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs

For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1

IRR=infusion-related reaction.

Interference with serological testing1

DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.

Reminders

  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®

Brochure on daratumumab and serological testing

Download brochure

Identification card to give to patients taking daratumumab

Download ID card

For relapsed or refractory multiple myeloma, after 2 prior therapies, EQUULEUS trial evaluated treatment with DARZALEX® + Pd1

An open-label, multi-cohort study

Patients had received prior treatment with a proteasome inhibitor (PI) and an immunomodulatory agent1

  • This trial included 103 patients who received DARZALEX® 16 mg/kg in combination with Pd and were treated with pre- and post-infusion medications. Patients were treated until disease progression or unacceptable toxicity1
  • Patients had a median of 4 prior lines of therapy1
  • Of the patients who were tested for cytogenetics, 74.7% were standard risk and 25.3% were high risk7

Patients were refractory to prior therapies1*

  • 89% to lenalidomide
  • 71% to bortezomib
  • 64% to bortezomib and lenalidomide

DPd=DARZALEX® (D) + pomalidomide (P) + dexamethasone (d); Pd=pomalidomide (P) + dexamethasone (d).

*Please note that this is not a full list of prior therapies.

Patient characteristics7

ECOG=Eastern Cooperative Oncology Group.

National Comprehensive Cancer Network® (NCCN®) Category 1, preferred

Daratumumab* (D) in combination with pomalidomide (P) and dexamethasone (d) is recommended by the NCCN Guidelines as a Category 1 preferred therapeutic option for patients with relapsed or refractory multiple myeloma, after 2 prior therapies

*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Efficacy demonstrated with DARZALEX® + Pd

CI=confidence interval; CR=complete response; ORR=overall response rate; Pd=pomalidomide (P) + dexamethasone (d); PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

*Efficacy results were based on ORR as determined by an Independent Review Committee (IRC) assessment using International Myeloma Working Group (IMWG) criteria.1

Median time to response

  • With DARZALEX® + Pd (n=61), median time to response was 1 month (range: 0.9 to 2.8 months)1
Median duration of response with DARZALEX® + Pd was 13.6 months (range: 0.9+ to 14.6+ months)1

DARZALEX® + Pd safety profile

Adverse reactions with incidence ≥10%1

Pd=pomalidomide (P) + dexamethasone (d).

aInfusion-related reaction includes terms determined by investigators to be related to infusion.

bEdema, edema peripheral, peripheral swelling.

cAcute tonsillitis, bronchitis, laryngitis, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection.

dLung infection, pneumonia, pneumonia aspiration.

eCough, productive cough, allergic cough.

fDyspnea, dyspnea exertional.

  • Infusion reaction includes terms determined by investigators to be related to infusion. Severe infusion reactions included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision1
  • The most frequent adverse reactions (≥20%) with DARZALEX® + Pd (DPd) were infusion reactions, diarrhea, constipation, nausea, vomiting, fatigue, pyrexia, upper respiratory tract infection, muscle spasms, back pain, arthralgia, dizziness, insomnia, cough, and dyspnea1
  • The overall incidence of serious adverse reactions was 49%. Serious adverse reactions reported in ≥5% of patients included pneumonia (7%)1

Treatment-emergent hematology laboratory abnormalities1

Pd=pomalidomide (P) + dexamethasone (d).

  • The discontinuation rate due to adverse reactions with DARZALEX® + Pd was 13%1
Frequency of IRRs (any grade) across clinical trials (N=2066)1

37%

of patients had IRRs with the Week 1 infusion

2%

of patients had IRRs with the Week 2 infusion

6%

of patients had IRRs with subsequent infusions

IRRs=infusion-related reactions.

Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs

For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1

IRR=infusion-related reaction.

Interference with serological testing1

DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.

Reminders

  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®

Brochure on daratumumab and serological testing

Download brochure

Identification card to give to patients taking daratumumab

Download ID card

For relapsed or refractory multiple myeloma, after 3 prior therapies, SIRIUS trial evaluated treatment with DARZALEX® monotherapy1

A phase 2, single-arm, open-label, multicenter trial in heavily pretreated patients8

All patients received prior treatment with a proteasome inhibitor (PI) and an immunomodulatory agent.8

Median number of prior therapies: 51

Patients were refractory to prior therapies1*

  • 97% to the last line of treatment
  • 95% to both a PI and an immunomodulatory agent
  • 90% to bortezomib
  • 88% to lenalidomide
  • 77% to alkylating agents

*Please note that this is not a full list of prior therapies.

Patient characteristics

ECOG=Eastern Cooperative Oncology Group.

This trial included 106 patients with relapsed or refractory multiple myeloma who were administered pre- and post-infusion medications and treated with DARZALEX® 16 mg/kg until unacceptable toxicity or disease progression.1

National Comprehensive Cancer Network® (NCCN®) Category 2A, useful in certain circumstances

Daratumumab* (D) monotherapy is recommended by the NCCN Guidelines as a Category 2A, useful in certain circumstances therapeutic option for patients with relapsed or refractory multiple myeloma, after 3 prior therapies

*Daratumumab includes both daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection and daratumumab (DARZALEX®) for intravenous infusion. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 12, 2022. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Overall response rate (ORR) with DARZALEX® monotherapy1*

CI=confidence interval; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

  • DARZALEX® achieved sCR + VGPR in 12% of patients1

*Efficacy results were based on ORR as determined by an Independent Review Committee (IRC) assessment using International Myeloma Working Group (IMWG) criteria.1

DARZALEX® provided a 7.4-month median duration of response (range: 1.2 to 13.1+ months)1

Median duration of response

Median time to response was 1 month (range: 0.9 to 5.6 months)1

DARZALEX® monotherapy safety profile

Adverse reactions with incidence ≥10%1

aInfusion-related reaction includes terms determined by investigators to be related to infusion.

bPneumonia also includes the terms streptococcal pneumonia and lobar pneumonia.

  • Infusion reaction includes terms determined by investigators to be related to infusion. Severe infusion reactions included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision1
  • Safety data were pooled from 3 open-label clinical studies of relapsed or refractory patients treated with DARZALEX® 16 mg/kg (n=156)1
4% of patients discontinued treatment due to adverse reactions; adverse reactions resulted in treatment delay for 24 patients (15%), most frequently for infections1

Treatment emergent Grade 3/4 laboratory abnormalities (≥10%)1

Frequency of IRRs (any grade) across clinical trials (N=2066)1

37%

of patients had IRRs with the Week 1 infusion

2%

of patients had IRRs with the Week 2 infusion

6%

of patients had IRRs with subsequent infusions

IRRs=infusion-related reactions.

Most IRRs occurred during the first infusion across clinical trials (N=2066)1
  • For 37% of patients, IRRs (any grade) occurred with the Week 1 (16 mg/kg) infusion; for 2% of patients, with the Week 2 infusion; and cumulatively, for 6% of patients with subsequent infusions
  • Median time to onset of an IRR was 1.5 hours (range: 0–73 hours)
  • Incidence of infusion modification due to reactions was 36%
  • DARZALEX® can cause severe IRRs. Severe IRRs included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision
  • Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®
Management of IRRs

For IRRs of any grade/severity, immediately interrupt the DARZALEX® infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion or treatment discontinuation of DARZALEX® as outlined below.1

IRR=infusion-related reaction.

Interference with serological testing1

DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion.

Reminders

  • Type and screen patients before starting DARZALEX®
  • Inform blood banks when a patient is on DARZALEX®
  • Identify any DARZALEX®-treated blood samples
  • Ask patients to tell other healthcare professionals that they've taken DARZALEX®

Brochure on daratumumab and serological testing

Download brochure

Identification card to give to patients taking daratumumab

Download ID card

DARZALEX FASPRO® combination therapy trial in newly diagnosed multiple myeloma

For newly diagnosed, transplant-ineligible multiple myeloma, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + VMP9

A multicohort, open-label trial (n=67)9
Primary endpoint in the DVMP arm: overall response rate (ORR).9
DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P); PD=progressive disease; QW=once weekly; Q3W=every 3 weeks; Q4W=every 4 weeks.
Patient characteristics
  • DVMP: eligible patients were required to have newly diagnosed multiple myeloma who are ineligible for transplant. The median age was 75 years old (range: 66–86 years): 46% were male; 69% were White, 8% Asian, and 2% Black or African American; 33% had International Staging System (ISS) Stage I, 45% had ISS Stage II, and 22% had ISS Stage III disease9

DARZALEX FASPRO® + VMP demonstrated a clinical response in newly diagnosed multiple myeloma9
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + bortezomib, melphalan, and prednisone arm was overall response rate (ORR).9
CI=confidence interval; CR=complete response; DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
*Based on treated subjects.
DVMP (95% CI: 78-95).

Safety profile for DARZALEX FASPRO® + VMP
Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO® in combination with bortezomib, melphalan, and prednisone.9
VMP=bortezomib (V) + melphalan (M) + prednisone (P).
aUpper respiratory tract infection includes nasopharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, tonsillitis, upper respiratory tract infection, and viral pharyngitis.
bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, pneumonia, and pneumonia bacterial.
cAbdominal pain includes abdominal pain and abdominal pain upper.
dFatigue includes asthenia and fatigue.
eEdema peripheral includes edema, edema peripheral, and peripheral swelling.
fCough includes cough and productive cough.
gOnly Grade 3 adverse reactions occurred.
The most common adverse reactions (≥20%) were upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.9
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy9
DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P); VMP=bortezomib (V) + melphalan (M) + prednisone (P).
aDenominator is based on the safety population treated with DVMP (n=67).

DARZALEX FASPRO® combination therapy trial in relapsed or refractory multiple myeloma

For relapsed or refractory multiple myeloma, after 1 prior therapy, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + Rd9

A phase 2, multicohort, open-label trial (n=65)9
Primary endpoint in the DRd arm: overall response rate (ORR)9
BMI=body mass index; DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics
  • DRd: the median age of patients was 69 years old (range: 33-82 years); 69% were male; 69% were White, and 3% Black or African American. Forty-two percent had ISS Stage I, 30% had ISS Stage II, and 28% had ISS Stage III disease. Patients had received a median of 1 prior line of therapy: 52% had a prior autologous
    stem-cell transplant (ASCT); 95% had received a prior proteasome inhibitor (PI); 59% had received a prior immunomodulatory agent, including 22% who received prior lenalidomide; and 54% of patients received both a prior PI and an immunomodulatory agent9

DARZALEX FASPRO® + Rd demonstrated a clinical response in relapsed or refractory multiple myeloma9
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + lenalidomide and dexamethasone arm was overall response rate (ORR).9
CI=confidence interval; CR=complete response; DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
*Based on treated subjects.
DRd (95% CI: 78-97).

Safety profile for DARZALEX FASPRO® + Rd
Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO® in combination with lenalidomide and dexamethasone.9
Rd=lenalidomide (R) + dexamethasone (d).
aFatigue includes asthenia and fatigue.
bUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection viral, rhinitis, sinusitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.
cPneumonia includes lower respiratory tract infection, lung infection, and pneumonia.
dBronchitis includes bronchitis and bronchitis viral.
eDyspnea includes dyspnea and dyspnea exertional.
fCough includes cough and productive cough.
gOnly Grade 3 adverse reactions occurred.
The most common adverse reactions (≥20%) were fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.9
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy9
DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
aDenominator is based on the safety population treated with DRd (n=65).

For relapsed or refractory multiple myeloma, after 1 to 3 prior therapies, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + Kd9

A phase 2, multicohort, open-label trial (n=66)9
Primary endpoint in the DKd arm: overall response rate (ORR).9
BMI=body mass index; DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics
DKd: the median age of patients was 61 years old (range: 42-84 years); 52% were male; 73% were White, and 3% Black or African American. Sixty-eight percent had ISS Stage I, 18% had ISS Stage II, and 14% had ISS Stage III disease. All patients received 1 prior line of therapy with exposure to lenalidomide and 62% of patients were refractory to lenalidomide. Seventy-nine percent had a prior autologous stem-cell transplant (ASCT).9

DARZALEX FASPRO® + Kd demonstrated a clinical response in relapsed or refractory multiple myeloma9
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + carfilzomib and dexamethasone arm was overall response rate (ORR).9
CI=confidence interval; CR=complete response; DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
*Based on treated subjects.
DKd (95% CI: 74-93).

Safety profile for DARZALEX FASPRO® + Kd
Adverse reactions (≥10%) in patients receiving DARZALEX FASPRO® in combination with carfilzomib and dexamethasone.9
Kd=carfilzomib (K) + dexamethasone (d).
aUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral pharyngitis, and viral upper respiratory tract infection.
bBronchitis includes bronchitis, and bronchitis viral.
cFatigue includes asthenia, and fatigue.
dEdema peripheral includes generalized edema, edema peripheral, and peripheral swelling.
eHypertension includes blood pressure increased, and hypertension.
fCough includes cough, and productive cough.
gDyspnea includes dyspnea, and dyspnea exertional.
hOnly Grade 3 adverse reactions occurred.
Clinically relevant adverse reactions in <10% of patients who received DARZALEX FASPRO® with carfilzomib and dexamethasone include9:
  • Gastrointestinal disorders: abdominal pain, constipation, pancreatitis
  • Infection and infestations: pneumonia, influenza, urinary tract infection, herpes zoster, sepsis
  • Metabolism and nutrition disorders: hyperglycemia, decreased appetite, hypocalcemia
  • Musculoskeletal and connective tissue disorders: muscle spasms, arthralgia
  • Nervous system disorders: paresthesia, dizziness, syncope
  • General disorders and administration site conditions: injection site reaction, infusion reactions, chills
  • Skin and subcutaneous tissue disorders: rash, pruritus
  • Cardiac disorders: cardiac failure
  • Vascular disorders: hypotension
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy9
DKd=DARZALEX FASPRO® (D) + carfilzomib (K) + dexamethasone (d); Kd=carfilzomib (K) + dexamethasone (d).
aDenominator is based on the safety population treated with DKd (n=66).

For relapsed or refractory multiple myeloma, after 1 prior therapy, APOLLO trial evaluated efficacy and safety of DARZALEX FASPRO® + Pd9

An open-label, randomized, active-controlled trial9
Primary endpoint was progression-free survival (PFS).9
DPd=DARZALEX FASPRO® (D) + pomalidomide (P) + dexamethasone (d); PD=progressive disease; Pd=pomalidomide (P) + dexamethasone (d); PI=proteasome inhibitor; QW=once weekly; Q2W=every 2 weeks; Q4W=every 4 weeks.
Patient characteristics9
  • The median age was 67 years (range: 35–90 years); 53% were male and 89% were White, <1% were Black or African American, and <1% were Asian
  • 45% had International Staging System (ISS) Stage I, 33% had ISS Stage II, and 22% had ISS Stage III disease
  • Patients had received a median of 2 prior lines of therapy (range: 1–5), with 11% of patients having received 1 prior line of therapy and 75% of patients having received 2 to 3 prior lines of therapy
  • All patients received a prior treatment with a proteasome inhibitor (PI) and lenalidomide, and 56% of patients received prior autologous stem cell transplant (ASCT)
  • The majority of patients were refractory to lenalidomide (80%), a PI (48%), or both an immunomodulatory agent and a PI (42%)

DARZALEX FASPRO® + Pd delivered significantly improved progression-free survival (PFS) in relapsed or refractory multiple myeloma vs Pd alone9
CI=confidence interval; DPd=DARZALEX FASPRO® (D) + pomalidomide (P) + dexamethasone (d); HR=hazard ratio; Pd=pomalidomide (P) + dexamethasone (d); PFS=progression-free survival.

Safety profile for DARZALEX FASPRO® + Pd vs Pd alone
Adverse reactions reported in ≥10% of patients and with at least a 5% greater frequency in the DARZALEX FASPRO® + Pd arm in APOLLO.9
Pd=pomalidomide (P) + dexamethasone (d).
aFatigue includes asthenia and fatigue.
bEdema peripheral includes edema, edema peripheral, and peripheral swelling.
cPneumonia includes atypical pneumonia, lower respiratory tract infection, pneumonia, pneumonia aspiration, pneumonia bacterial, and pneumonia respiratory syncytial viral.
dUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, and viral upper respiratory tract infection.
eCough includes cough, and productive cough.
fOnly grade 3 adverse reactions occurred.
gGrade 5 adverse reactions occurred, n=3 (2.0%) in the DARZALEX FASPRO® + Pd arm and n=2 (1.3%) in the Pd arm.
  • The most common adverse reactions (≥20%) were fatigue, pneumonia, upper respiratory tract infection, and diarrhea9
  • Serious adverse reactions occurred in 50% of patients who received DARZALEX FASPRO® + Pd. The most frequent serious adverse reactions in >5% of patients who received DARZALEX FASPRO® + Pd were pneumonia (15%) and lower respiratory tract infection (12%). Fatal adverse reactions occurred in 7% of patients who received DARZALEX FASPRO® + Pd9
  • Permanent treatment discontinuation due to an adverse reaction occurred in 2% of patients who received DARZALEX FASPRO® + Pd9
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® + Pd vs Pd alone in APOLLO9
Pd=pomalidomide (P) + dexamethasone (d).
aDenominator is based on number of subjects with a baseline and post-baseline laboratory value for each laboratory test: n=148 for DARZALEX FASPRO® + Pd and n=149 for Pd.