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CAR T-cell Therapy

Idecabtagene Vicleucel + Lenalidomide for Multiple Myeloma(KarMMa-9 Trial)

Local Institution - 0069, Oslo, Norway

idecabtagene vicleucel +3 morePhase 3RecruitingResearch Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.

Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to approximately 49 months after the first participant is randomized

Awards & highlights

No Placebo-Only Group

Pivotal Trial

KarMMa-9 Trial Summary

This trial compares the safety, efficacy and tolerance of a new drug to an existing one in people with multiple myeloma who have had a stem cell transplant.

Eligible Conditions

Multiple Myeloma

KarMMa-9 Trial Eligibility Criteria

Inclusion Criteria

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

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Adults who have newly diagnosed multiple myeloma and have had high-dose chemotherapy and stem cell transplantation, without further treatment. However, if you received a short course of lenalidomide maintenance therapy, you may still be eligible.

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You must have received a specific type of treatment for your condition and had a certain procedure done within a specific time frame. You should not have experienced worsening of the disease since starting the treatment.

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You must have shown a good response to treatment at the time you agree to participate.

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You should be able to perform daily activities with little or no difficulty due to your medical condition. If you have moderate difficulty due to pain from myeloma-related bone lesions, the doctor can decide if you can still participate.

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Any side effects from previous treatments, except for hair loss and mild nerve pain, must be mostly gone.

KarMMa-9 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 49 months after the first participant is randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 49 months after the first participant is randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 49 months after the first participant is randomized 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

Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])

Duration of Response (DOR)

Event-Free Survival (EFS)

+15 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

KarMMa-9 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment4 Interventions

Group II: Arm BActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Fludarabine

2012

Completed Phase 3

~1090

Cyclophosphamide

1995

Completed Phase 3

~3790

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,602 Previous Clinical Trials

4,047,633 Total Patients Enrolled

79 Trials studying Multiple Myeloma

15,745 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Can you appraise the potential risks to participants in Arm A?

"There is existing scientific evidence for the efficacy and safety of Arm A, thus it has been assigned a rating of 3 on our 1-3 scale."

Answered by AI

How many healthcare facilities are conducting this research experiment?

"Mayo Clinic in Arizona - Scottsdale, University of California Davis (UC Davis) Comprehensive Cancer Center, Colorado in Arizona - Scottsdale, University of California Davis (UC Davis) Comprehensive Cancer Center, Colorado and Stanford University Medical Center are just a handful of the 107 participating sites for this trial."

Answered by AI

Are there any vacancies to join this clinical experiment?

"This research trial, which went live on September 27th 2023 and was last updated on the 22nd of that month, is not currently recruiting patients. Nevertheless, there are 812 clinical trials actively looking for participants across numerous disciplines."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

2023. "A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045806.

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