RecruitingPhase 2NCT06376526

IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial cOmbination Therapy to Pursue Deeper Responses With Linvoseltamab ANd Delay Transplant

Sponsor

Dickran Kazandjian, MD

Enrollment

28 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new transplant strategy for people with newly diagnosed multiple myeloma (a blood cancer) who had a very good response to initial treatment but still have tiny amounts of detectable cancer remaining (called MRD-positive). **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You received initial treatment with a combination of drugs including at least two of the following: an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and/or an anti-CD38 antibody - You achieved a very good partial response (VGPR) or better but still have detectable disease at a very sensitive level (MRD-positive) **You may NOT be eligible if...** - Your myeloma has relapsed - You achieved a complete response with undetectable disease (MRD-negative) - You did not respond well enough to initial treatment 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.

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Interventions

BIOLOGICALLinvoseltamab

Participants will be administered Linvoseltamab intravenously (IV), using a step-up dosing schedule as follows: * Cycle 1, Day 1: 5mg * Cycle 1, Day 8: 25mg * Cycle 1, Days 15 and 22: 200mg * Cycles 2 and 3, Days 1, 8, 15 and 22: 200mg * Cycle 4, Days 1 and 15: 200mg. For participants who are MRD-positive after four (4) cycles of study treatment: * Cycles 5 and 6, Days 1 and 15: 200 mg