Elranatamab, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma, a Clinical and Correlative Phase 2 Study
University of Miami
Summary
The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the IMWG diagnostic criteria and measurable disease within the past 4 weeks (or past 8 weeks if patient received pre-study MM therapy) based on one of the following: * Serum monoclonal protein ≥ 1.0 g/dL * Urine monoclonal protein ≥ 200 mg/24 hour * Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal kappa/lambda ratio Note: * Patients who have evaluable disease based on samples other than urine do not need to have urine evaluated for initial or subs…
Interventions
- DrugLenalidomide
Participants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles.
- DrugDexamethasone
Participants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6.
- DrugElranatamab
Participants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles.
Location
- University of MiamiMiami, Florida