CAR-T Therapy for Multiple Myeloma
(CARTITUDE-4 Trial)

Recruiting in Palo Alto (17 mi)

+123 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment called JNJ-68284528 (cilta-cel) for patients with multiple myeloma who haven't responded to other treatments. The treatment uses modified immune cells to better recognize and attack cancer cells. The goal is to see if this new treatment works better than standard therapies. Cilta-cel was approved earlier this year.

Eligibility Criteria

This trial is for people with multiple myeloma who've had 1-3 prior treatments including specific drugs, are lenalidomide-refractory, and meet certain lab value criteria. Not eligible if they've had CAR-T or BCMA-targeted therapies, recent high-dose steroids, antibody treatment within 21 days, chemotherapy within 14 days, or have unresolved severe side effects from past cancer therapy.

Inclusion Criteria

My myeloma has worsened within 6 months after my last treatment.

My condition did not improve after taking lenalidomide.

Your recent medical tests must show specific results.

+2 more

Exclusion Criteria

I have taken a lot of steroids, like prednisone, recently.

I do not have severe nerve pain or damage.

I have not received monoclonal antibody treatment in the last 21 days.

+6 more

Participant Groups

The study compares JNJ-68284528 (a CAR-T cell therapy targeting BCMA) against standard therapies: PVd (Pomalidomide with Bortezomib and Dexamethasone) or DPd (Daratumumab with Pomalidomide and Dexamethasone), to see which is more effective for relapsed multiple myeloma patients.

2Treatment groups

Experimental Treatment

Group I: Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])Experimental Treatment1 Intervention

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 JNJ-68284528 (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 JNJ-68284528 (cilta-cel) infusion 0.75 \* 10\^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).

Group II: Arm A: PVd or DPd (Standard Therapy)Experimental Treatment4 Interventions

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.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: