VRd + CAR-T Therapy for Multiple Myeloma
(CARTITUDE-5 Trial)

Recruiting in Palo Alto (17 mi)

+205 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

Trial Summary

What is the purpose of this trial?The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemo with stem cell transplant due to age or other health issues. They must have measurable disease, be in good physical condition (able to perform daily activities without help), and women able to bear children must test negative for pregnancy.

Inclusion Criteria

I am not a candidate for high-dose chemotherapy with stem cell transplant due to my age, health conditions, or it's not my first treatment choice.

I am a woman who can have children and have had 2 negative pregnancy tests before starting VRd treatment.

I am fully active or can carry out light work.

+7 more

Exclusion Criteria

You have a frailty index score of 2 or higher based on the Myeloma Geriatric Assessment.

I have not received a live vaccine in the last 4 weeks.

I experience significant nerve pain or damage.

+8 more

Participant Groups

The study compares two treatments: one group receives VRd (Bortezomib, Lenalidomide, Dexamethasone) followed by a CAR-T therapy called cilta-cel; the other gets VRd followed by Rd (Lenalidomide and Dexamethasone). The main goal is to see which treatment better stops the cancer from progressing.

2Treatment groups

Experimental Treatment

Group I: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)Experimental Treatment6 Interventions

Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 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).

Group II: Arm A: VRd+Rd (Standard Therapy)Experimental Treatment3 Interventions

Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Velcade for: