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® Weeks 1–6 (Cycle 1): QW Weeks 7–54 (Cycles 2–9): Q3W Week 55 until PD (Cycles 10+): Q4W |
DARZALEX FASPRO® 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
Weeks 7–54 (Cycles 2–9): QW |
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