PLEIADES Study Design

Supporting evidence for combination therapy

In the PLEIADES trial, DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated response in multiple regimens, including DVMP in patients who are newly diagnosed and ineligible for transplant, and DRd in patients with relapsed or refractory multiple myeloma.1

PLEIADES is a phase 2, multicohort, open-label trial evaluating the efficacy and safety of DARZALEX FASPRO® (n=132)

  • Primary endpoint in the DVMP and DRd arms: Overall response rate (ORR)
Adult patients with newly diagnosed multiple myeloma who are ineligible for transplant, or with relapsed or refractory multiple myeloma1
Multi-arm cohort
Newly diagnosed patients ineligible for transplant
(n=67)
Relapsed or refractory patients
(n=65)
DVMP DRd

DARZALEX FASPRO®
Daratumumab 1,800 mg and hyaluronidase 30,000 units:

Weeks 1–6 (Cycle 1): QW

Weeks 7–54 (Cycles 2–9): Q3W

Week 55 until PD (Cycles 10+): Q4W

DARZALEX FASPRO®
Daratumumab 1,800 mg and hyaluronidase 30,000 units:

Weeks 1–8 (Cycle 1): QW

Weeks 9–24 (Cycles 2–9): Q2W

Week 25 until PD (Cycles 10+): Q4W

Bortezomib 1.3 mg/m2:

Weeks 1–6: Twice weekly
(8 doses: Weeks 1, 2, 4, and 5)

Weeks 7–54 (Cycles 2–9): QW
(Weeks 1, 2, 4, and 5 for 8 more 6-week cycles; 4 doses per cycle)

Lenalidomide 25 mg:

Once daily on Days 1–21 of each 28-day cycle

Melphalan 9 mg/m2 and prednisone 60 mg/m2:

Orally (Days 1–4 of Cycles 1–9)

Dexamethasone 40 mg (20 mg for patients >75 years old or BMI <18.5):

QW

BMI=body mass index; DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P); PD=progressive disease; QW=once weekly; Q2W=every 2 weeks; 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): 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 disease
  • DRd: The median age of patients was 69 years old (range: 33–82); 69% were male; 69% were White, and 3% Black or African American. 42% 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 agent

See the clinical results from the PLEIADES trial