For newly diagnosed, transplant-ineligible multiple myeloma, PLEIADES trial evaluated efficacy and safety of DARZALEX FASPRO® + VMP1

A multicohort, open-label trial (n=67)1
Primary endpoint in the DVMP arm: overall response rate (ORR).1
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 disease1

DARZALEX FASPRO® + VMP demonstrated a clinical response in newly diagnosed multiple myeloma1
In the PLEIADES trial, the primary endpoint in DARZALEX FASPRO® + bortezomib, melphalan, and prednisone arm was overall response rate (ORR).1
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.1
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.1
Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy1
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).
NCCN Guidelines recommendations for daratumumab-containing regimens