First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma

  • End date
    Dec 16, 2022
  • participants needed
  • sponsor
    Regeneron Pharmaceuticals
Updated on 12 June 2021
proteasome inhibitor
refractory multiple myeloma
immunotherapeutic agent
immunomodulatory imide drug


The primary objectives of the study are:

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 symptoms
  • To evaluate the safety and tolerability of REGN5458
  • To evaluate the PK properties of REGN5458
  • To characterize the immunogenicity of REGN5458

Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment REGN5458
Clinical Study IdentifierNCT03761108
SponsorRegeneron Pharmaceuticals
Last Modified on12 June 2021


Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 1
Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria
Phase 1 Dose Escalation: Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including
Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR
Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment
Phase 2: Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD
Adequate hematologic and hepatic function as defined in protocol
Serum creatinine clearance by Cockcroft-Gault >30 mL/min

Exclusion Criteria

Diagnosis of plasma cell leukemia, amyloid light-chain amyloidosis,Waldenstrm macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Patients with known MM brain lesions or meningeal involvement
History of neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment are excluded
Continuous systemic corticosteroid treatment with more than 10 mg of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
Treatment with any systemic standard or investigational anti-myeloma therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bispecific antibody) or BCMA-directed CAR T therapy
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; or other uncontrolled infection
Has known allergy or hypersensitivity to components of REGN5458
History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
Known hypersensitivity to both allopurinol and rasburicase
Pregnant or breastfeeding women
Women of childbearing potential and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
Another malignancy in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent
Note: Other protocol defined inclusion / exclusion criteria apply
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