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CAR T-cell Therapy

Ide-cel + Lenalidomide for Multiple Myeloma (KarMMa-9 Trial)

Phase 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Be older than 18 years old
Must not have
Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
Participant with known central nervous system involvement with myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 49 months after the first participant is randomized
Awards & highlights

Summary

"This trial aims to see if adding ide-cel to lenalidomide maintenance treatment is more effective, safe, and tolerable compared to using lenalidomide maintenance alone in adults with

Who is the study for?
This trial is for adults with newly diagnosed Multiple Myeloma who haven't responded well to a stem cell transplant. Participants should be in good health otherwise and not have any other major illnesses or conditions that could interfere with the study.
What is being tested?
The study is testing if adding idecabtagene vicleucel (ide-cel) to lenalidomide maintenance therapy works better than lenalidomide alone after a suboptimal response to stem cell transplantation in treating Multiple Myeloma.
What are the potential side effects?
Potential side effects include reactions related to immune system activation, such as fever and chills, fatigue, nausea, and possible organ inflammation. Lenalidomide may cause blood clots, rash or itching, diarrhea, and impact blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from previous treatment side effects, except for hair loss and mild nerve pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled infections.
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My myeloma has spread to my brain or spinal cord.
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My multiple myeloma does not produce detectable levels of M protein.
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I have had a stem cell transplant or gene/cell therapy for cancer.

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
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

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
Cyclophosphamide
2010
Completed Phase 4
~2320
Lenalidomide
2005
Completed Phase 3
~1340
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,931 Total Patients Enrolled
145 Trials studying Multiple Myeloma
41,185 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,027 Total Patients Enrolled
90 Trials studying Multiple Myeloma
21,810 Patients Enrolled for Multiple Myeloma
~412 spots leftby Mar 2031
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