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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

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
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.
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.
You must have shown a good response to treatment at the time you agree to participate.
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.
Any side effects from previous treatments, except for hair loss and mild nerve pain, must be mostly gone.

KarMMa-9 Trial Timeline

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 3
Completed Phase 3

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
~412 spots leftby Mar 2031