In the phase 1 portion of the study: 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).
In the phase 2 portion of the study: To assess the anti-tumor activity of REGN5458 as
measured by objective response rate (ORR)
The secondary objectives of the study are:
In the phase 1 dose escalation portion:
To assess the preliminary anti-tumor activity of REGN5458 as measured by ORR, duration
of response (DOR), progression-free survival (PFS), rate of minimal residual disease
(MRD) negative status, and overall survival (OS)
To evaluate the pharmacokinetic (PK) properties of REGN5458
To characterize the immunogenicity of REGN5458
In the phase 2 portion only:
To assess the anti-tumor activity of REGN5458 as measured by ORR, DOR, PFS, rate of MRD
negative status, and OS
To evaluate the effects of REGN5458 on patient-reported quality of life, functions and
To evaluate the safety and tolerability of REGN5458
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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