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Proteasome Inhibitor

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

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

CARTITUDE-5 Trial 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.Check my eligibility

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.See study design

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.

CARTITUDE-5 Trial 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.

CARTITUDE-5 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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

CARTITUDE-5 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 3

~1100

Bortezomib

2005

Completed Phase 2

~1140

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,658 Total Patients Enrolled

70 Trials studying Multiple Myeloma

18,767 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,255 Total Patients Enrolled

49 Trials studying Multiple Myeloma

13,734 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04923893 — Phase 3

Multiple Myeloma Research Study Groups: Arm A: VRd+Rd (Standard Therapy), Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04923893 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04923893 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please share any other studies that have included Cilta-cel as a treatment?

"Cilta-cel was first studied in 1997 and, as of now, 2703 clinical trials have been completed. There are 1561 active studies currently, many of which are based in Orlando and Alberta."

Answered by AI

What are the primary functions of Cilta-cel?

"Cilta-cel is an effective medication for synovitis. Additionally, it has been shown to help patients with ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and lung cancers."

Answered by AI

Are there any dangers that have been linked with Cilta-cel treatments?

"Cilta-cel falls into the third phase of clinical trials, which is why our team believes that it is safe. There is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there available positions for volunteers in this experiment?

"The most recent information on clinicaltrials.gov indicates that this study is still recruiting patients. It was first posted on August 19th, 2021 and was last edited on November 3rd, 2020. They are looking for 650 individuals total from 27 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

2021. "A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04923893.

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