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Linvoseltamab and Lenalidomide for Multiple Myeloma

This study is testing if adding linvoseltamab to lenalidomide (L2) maintenance therapy can help people with newly-diagnosed multiple myeloma (a type of blood cancer) achieve or regain "minimal residual disease negative" (MRD-) status. MRD- means there are no detectable cancer cells left. The goal is to see if this combination can get rid of remaining cancer cells, keep the disease controlled for longer, and extend the time your treatment works. You may be able to join if you have newly-diagnosed multiple myeloma and have already received certain initial combination therapies. The study plans to enroll 32 participants. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 32 participants. It is testing the combination of linvoseltamab and lenalidomide.
What's involved
Participants will receive linvoseltamab intravenously for up to 24 cycles, each lasting 28 days, with varying doses in the first cycles. You will also take 10mg of lenalidomide daily by mouth for 21 days of each 28-day cycle, starting on Cycle 2 Day 1.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 12 months, looking at the rate of becoming MRD-negative.

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NCT06910124

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

Recruiting
PHASE2All AgesInterventionalTreatment
Dickran Kazandjian, MD
~32 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:LinvoseltamabLenalidomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimum Residual Disease Negative Conversion Rate
Measured over 12 months

Conditions

Multiple Myeloma

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Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Dickran Kazandjian, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Dickran Kazandjian, MD
[email protected]
305-243-5001
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Treatment with corticosteroids for MM or other indications is permitted.
Prior radiation therapy and surgery is permitted. 2. Patients who are receiving any other investigational agents unless deemed not to interfere with the study by the Principal Investigator (PI). 3. Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration. 4. Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy. 5. Patient has any of the following:
a. Human immunodeficiency virus (HIV)-positive with 1 or more of the following: i. History of acquired immune deficiency syndrome (AIDS)-defining conditions Cluster of differentiation 4 count \< 350 cells/mm3 ii. Detectable viral load during screening or within 6 months prior to screening iii. Not receiving highly active anti-retroviral therapy iv. Had a change in antiretroviral therapy within 6 months of the start of screening v. Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the PI
b. Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV) DNA positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-Hepatitis-C\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. Exception: Patients with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.

What this trial measures

  • Minimum Residual Disease Negative Conversion Rate12 months

    The number of patients who experience MRD negativity (10\^-5 sensitivity by 12 cycles of linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients. MRD negativity rate (\<10\^-5) by 12 cycles of linvoseltamab