A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cilta-cel — DRUG
  Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).
• Pomalidomide — DRUG
  Pomalidomide 4 mg will be administered orally.
• Bortezomib — DRUG
  Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).
• Dexamethasone — DRUG
  Dexamethasone 20 mg/day (10mg/day for participants \>75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants \>75 years of age) in DPd treatment.
• Daratumumab — DRUG
  Daratumumab 1800 mg will be administered SC.

Study Details

The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

Key Dates

Start date

Jun 12, 2020

Status verified

May 2026

Primary completion

May 1, 2024

Completion

Apr 9, 2029

Study Design

Enrollment

419 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: PVd or DPd (Standard Therapy)
  Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m\^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
• Experimental: Arm B: (Ciltacabtagene Autoleucel [Cilta-cel])
  Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram \[mg\]/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily, for 3 days), and cilta-cel infusion 0.75 \* 10\^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years) ]

Locations (19)

Find similar trials in Birmingham, AL

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Family Study of Lymphoproliferative Disorders
  Recruiting · Mayo Clinic · Rochester, Minnesota
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
  Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio