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CAR T-cell Therapy

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

Phase 3

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

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.

Who is the study for?

Adults over 18 with newly diagnosed Multiple Myeloma who've had a stem cell transplant but didn't respond well. They should have completed specific induction therapy and be in good physical condition, without severe ongoing infections or previous gene/cell therapies.Check my eligibility

What is being tested?

The trial is testing if adding idecabtagene vicleucel (ide-cel) to lenalidomide maintenance therapy is better than lenalidomide alone for Multiple Myeloma patients post-transplant with suboptimal response.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation, blood cell count changes, infection risk increase, and possible organ inflammation due to ide-cel; plus known risks of lenalidomide like blood clots and bone marrow suppression.

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

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

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,446 Total Patients Enrolled

87 Trials studying Multiple Myeloma

29,302 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 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.