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CAR T-cell Therapy

Arm A 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

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 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.Check my eligibility

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.See study design

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.

KarMMa-9 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have recovered from previous treatment side effects, except for hair loss and mild nerve pain.

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

Cyclophosphamide

1995

Completed Phase 3

~3770

Lenalidomide

2005

Completed Phase 3

~1480

Fludarabine

2012

Completed Phase 3

~1080

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

641 Previous Clinical Trials

129,855 Total Patients Enrolled

144 Trials studying Multiple Myeloma

41,481 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbIndustry Sponsor

2,646 Previous Clinical Trials

4,130,525 Total Patients Enrolled

88 Trials studying Multiple Myeloma

29,920 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.

Has Arm A received approval from the FDA?

"Our team at Power has rated the safety of Arm A as 3 on a scale from 1 to 3, given that this trial is in Phase III and has gathered evidence supporting both effectiveness and safety through numerous iterations."

Answered by AI

Is the enrollment for this research study still ongoing?

"Indeed, the details on clinicaltrials.gov indicate an ongoing patient recruitment for this research endeavor. The trial was first posted on October 16th, 2023, with the most recent update made on May 1st, 2024. A total of 618 individuals are sought after across a network of 115 sites participating in this study."

Answered by AI

Are there a multitude of medical facilities in the United States conducting this research study?

"There are 115 active recruitment sites for this research, including reputable centers such as AOU Policlinico Umberto I in Rome, Banner MD Anderson Cancer Center in Gilbert, and Mayo Clinic in Arizona - Scottsdale."

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/NCT06399393.

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