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CAR T-cell Therapy

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

Paris, France
Phase 3
Waitlist Available
Research Sponsored by Celgene
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
No Placebo-Only Group
Pivotal 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.

See full description
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.
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.

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

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
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Percentage of Participants with Complete Response (CR)
+2 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.

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
~2240
Cyclophosphamide
2010
Completed Phase 4
~2280
Fludarabine
2012
Completed Phase 4
~1830

Find a Location

Closest Location:Local Institution - 0123· Ann Arbor, MI

Who is running the clinical trial?

CelgeneLead Sponsor
648 Previous Clinical Trials
130,564 Total Patients Enrolled
146 Trials studying Multiple Myeloma
40,906 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,709 Previous Clinical Trials
4,124,739 Total Patients Enrolled
91 Trials studying Multiple Myeloma
21,775 Patients Enrolled for Multiple Myeloma
~412 spots leftby Mar 2031
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