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
Dickran Kazandjian, MD
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction treatment. 2. Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38). 3. Documentation of attaining a best response of very good partial response (VGPR) or better but MRD+ (sensitivity: ≤10\^-5) after at least 4 cycles of combination ther…
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
Location
- University of MiamiMiami, Florida