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Proteasome Inhibitor

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

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.

Eastern Cooperative Oncology Group Performance Status grade of 0 or 1

Must not have

Peripheral neuropathy or neuropathic pain Grade 2 or higher

Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing if a new treatment for multiple myeloma is better than the current standard of care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to CAR-T therapy like fever and low blood pressure, nerve damage from Bortezomib causing numbness or pain, weakened bones or clots from Lenalidomide, and increased sugar levels or mood changes from Dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or can carry out light work.

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I am not a candidate for high-dose chemotherapy with stem cell transplant.

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I have been diagnosed with multiple myeloma according to IMWG standards.

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I am a woman who can have children, have had 2 negative pregnancy tests, and agree to more tests during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience significant nerve pain or damage.

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I have previously undergone CAR-T cell therapy.

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I do not need help breathing all the time.

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I have not had a stroke or seizure in the last 6 months.

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I have hepatitis B.

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I am infected with Hepatitis C.

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I have or had brain or spinal cord involvement by my cancer.

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I am receiving treatment targeting BCMA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers

Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence

Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)

+17 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cilta-cel

2022

Completed Phase 2

~90

Fludarabine

2012

Completed Phase 4

~1860