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

Part of paid clinical trials in Miami, Florida.

Sponsor
Dickran Kazandjian, MD
Study ID
NCT06910124
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linvoseltamab — BIOLOGICAL
    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
  • Lenalidomide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Jan 2026
Primary completion
Dec 2, 2032
Completion
Dec 2, 2032

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Linvoseltamab Treatment Group
    Participants in this group are currently receiving lenalidomide maintenance therapy for ≤12 months will have linvoseltamab added to the lenalidomide maintenance therapy and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years
  • Experimental: Cohort 2 - Lenalidomide Treatment Group
    Participants in this group are currently receiving lenalidomide maintenance therapy but have relapsed disease within 12 months of starting maintenance will have Linvoseltamab added to lenalidomide maintenance and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years

Primary Outcome Measure

Minimum Residual Disease Negative Conversion Rate [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Dickran Kazandjian, MD
[email protected]
305-243-5001
Dickran Kazandjian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Miami· Miami, FL

Related Studies