RecruitingPhase 2NCT06910124

Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse

Alpe d'Huez Study: A Parallel Two-Cohort Study of Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse


Sponsor

Dickran Kazandjian, MD

Enrollment

32 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-. 2. Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status. 3. Increase the length of time that participants' disease responds to treatment. The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding linvoseltamab (a bispecific antibody that targets two proteins on myeloma cells) to lenalidomide (a standard maintenance therapy) can help newly diagnosed multiple myeloma patients who are already in remission achieve even deeper remissions or recover their remission after relapse. **You may be eligible if...** - You have been diagnosed with newly diagnosed multiple myeloma - You previously received a triplet or quadruplet treatment containing at least two of: an immunomodulatory drug, a proteasome inhibitor, and/or an anti-CD38 antibody - You are currently on lenalidomide maintenance therapy (started within the last 12 months) - Your current response is a partial response, very good partial response, or complete response — or you have recently had a relapse **You may NOT be eligible if...** - You are on a different maintenance therapy - You have had more than one prior treatment line for active myeloma - Your overall health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALLinvoseltamab

Participants will receive Linvoseltamab intravenously (IV) according to the following schedule and regimen, for up to 24 cycles, each cycle lasting 28 days: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 25mg * Cycle 1 Days 15, 22: 100mg * Cycles 2 and 3, Days 1, 8, 15, 22: 100mg * Cycles 3 and 6, Days 1 and 15: 100mg * Cycles 7 through 24: 100mg

DRUGLenalidomide

Participants will take 10mg of Lenalidomide maintenance therapy standard of care by mouth daily from days 1 through 21 of each 28 day cycle of Linvoseltamab therapy. Lenalidomide therapy will begin on Cycle 2 Day 1 of Linvoseltamab therapy.


Locations(1)

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06910124


Related Trials