Actively Recruiting
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
Led by Dickran Kazandjian, MD · Updated on 2026-01-08
32
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
D
Dickran Kazandjian, MD
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of newly diagnosed multiple myeloma (NDMM) confirmed before any treatment
- Received initial combination therapy with at least two of the following: immunomodulatory drug, proteosome inhibitor, and/or anti-CD38
- Received induction therapy with or without high-dose melphalan and autologous stem cell transplant (HDM-ASCT)
- Receiving lenalidomide maintenance therapy for 12 months or less
- For Cohort 1: Current response is partial response (PR), very good partial response (VGPR), or complete response (CR) but MRD positive by FDA-cleared NGS Adaptive clonoseq assay
- For Cohort 2: Relapse from initial CR without meeting progression criteria, with low M-protein and/or MRD positive status
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 3 or less
- Adequate organ function including specific blood counts and liver and kidney function levels
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception; fertile males must use contraception
- Able and willing to provide informed consent
- Able and willing to comply with clinic visits and study procedures
You will not qualify if you...
- Prior systemic therapies for multiple myeloma other than initial IMiD/PI/anti-CD38/HDM-ASCT combination therapy
- Receiving other investigational agents unless approved by Principal Investigator
- Received live attenuated vaccine within 4 weeks before study treatment
- Contraindications to medications used for infusion reactions or prophylaxis
- HIV positive with specific conditions or not on stable antiretroviral therapy
- Active hepatitis B or C infection unless successfully treated and undetectable viral load
- History of allergic reactions to similar study agents
- Female patients breastfeeding during or up to 3 months after study treatment
- Participants planning to father a child during study or within 3 months after last dose
- Certain severe cardiac conditions including advanced heart failure, recent myocardial infarction, significant arrhythmias, or unstable cardiac disease
- Uncontrolled illnesses such as active infections, autoimmune diseases (with exceptions), or psychiatric conditions limiting compliance
- History of neurodegenerative or CNS movement disorders or recent seizures unless deemed low risk
- Active malignancy other than multiple myeloma needing treatment in past 6 months
- Any condition compromising patient well-being or study compliance as judged by Investigator
- Patients with impaired decision-making capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
D
Dickran Kazandjian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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