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Recruiting Phase 2 NCT06997081

ERd Combination Treatment in Newly Diagnosed Multiple Myeloma

Trial Parameters

Condition Multiple Myeloma
Sponsor University of Miami
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 104
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-16
Completion 2030-09-30
Interventions
LenalidomideDexamethasoneElranatamab

Brief 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 Criteria

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 subsequent response assessments. * Because the primary endpoint is MRD negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease (e.g., M-spike \<1.0 g/dL) may also be enrolled in line with the International Myeloma Working Group (IMWG) MM response criteria. 2. Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell pro

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