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 05, 2020
Results indicated that 95% (n = 18) of 19 patients who responded to treatment experienced a very good partial response (VGPR) or better and 42% achieved a complete response (CR) or a stringent CR (sCR).
At a median follow-up of 2.6 months, patients who received the agent at a dose of 3 mg, 6 mg, or 12 mg (n = 24; dosing levels [DL] 1-3) experienced an overall response rate (ORR) of 29.2%; 20.9% of these responders experienced a CR or sCR, while 4.2% had VGPR or better and 4.2% achieved a partial response (PR).
The ORR was higher among those who received REGN5458 at a dose of 24 mg or 48 mg (n = 17; DL 4-5), at 41.2%, with 11.8% of patients collectively experiencing a CR (11.8%)/sCR (5.9%) and 23.5% of patients achieving a VGPR. Patients who received 96 mg (n = 8; DL 6), the highest dose of the antibody evaluated on the trial, experienced the highest ORR, at 62.5%; all of these patients had a VGPR.
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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