The primary objectives of the study are: Phase 1: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended Phase 2 dose regimen (RP2DR) of REGN5458 as monotherapy in patients with relapsed or refractory Multiple Myeloma (MM) who have exhausted therapeutic options Phase 2: To assess the preliminary anti-tumor activity of REGN5458 The secondary objectives of the study are: - To evaluate the pharmacokinetic (PK) properties of REGN5458 - To characterize the immunogenicity of REGN5458 - To assess the preliminary anti-tumor activity of REGN5458 (Phase 1) - To evaluate the safety and tolerability of REGN5458 (Phase 2) - To evaluate the correlation between the activity of REGN5458 and PK (Phase 2)
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion / exclusion criteria apply
The following is a listing of trial locations that are open and accepting patients.
New Brunswick, NJ
New Brunswick, NJ
December 08, 2019
Results were presented today at the American Society of Hematology (ASH) Annual Meeting from the first two dose groups (3 mg and 6 mg weekly doses).
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