Multiple Myeloma Clinical Trial

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

Summary

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 one or more recommended phase 2 dose regimens (RP2DRs) 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 separately in cohorts 1 and 2, as measured by objective response rate (ORR) and as determined by an Independent Review Committee (IRC) in patients who have progressed on or after 3 prior lines of therapy or who are triple-refractory (defined as refractory to a(n) proteasome inhibitor (PI), immunomodulatory imide (IMiD) drug (s), and anti-cluster of differentiation 38 (anti-CD38) monoclonal antibody).

The secondary objectives of the study are:

In the phase 1 dose escalation portion:

To assess the preliminary anti-tumor activity of REGN5458 as determined by the investigator and 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 for each cohort:

To assess the anti-tumor activity of REGN5458 as measured by: ORR, DOR, PFS, as determined by an IRC and the investigator, rate of MRD negative status and OS
To evaluate the effects of REGN5458 on health-related quality of life (HRQoL) and patient-reported functions and symptoms
To evaluate the safety and tolerability of REGN5458
To evaluate the PK properties of REGN5458
To characterize the immunogenicity of REGN5458

View Eligibility Criteria

Eligibility Criteria

Key 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 as defined in the protocol.

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 either:

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. In addition, patients must be penta-exposed (ie, having prior exposure to 2 PIs, 2 IMiDs [lenalidomide and pomalidomide], and 1 anti-CD38 monoclonal antibody).

Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or less than 25% response to therapy.

Key Exclusion Criteria:

Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Patients with known MM brain lesions or meningeal involvement
Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs, and BCMA CAR T cells. Note: BCMA antibody-drug conjugates are not excluded
History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment

Note: Other protocol defined inclusion / exclusion criteria apply

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

282

Study ID:

NCT03761108

Recruitment Status:

Active, not recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 30 Locations for this study

See Locations Near You

University of Miami Hospital/Sylvester Comprehensive
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis Indiana, 46202, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
The Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center, Herbert Irving Pavilion
New York New York, 10032, United States
The Ohio State University, James Cancer Hospital
Columbus Ohio, 43210, United States
Oregon Health Science University OHSU
Portland Oregon, 97239, United States
University of Texas MD Anderson Clinic
Houston Texas, 77030, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Ziekenhuis Netwerk Antwerpen (ZNA)- Stuivenberg
Antwerp , 2060, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Universitaetsklinikum Essen
Essen , 45147, Germany
University Medicine Mainz
Mainz , 55131, Germany
Universitatsklinikum Wurzburg
Würzburg , 6 970, Germany
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Soul National University Hospital Jongno-gu
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System Seodaemun-gu
Seoul , 03722, Korea, Republic of
Seoul St.Mary's Hospital, The Catholic University of Korea Seocho-gu
Seoul , 137-7, Korea, Republic of
Clinica universidad de Navarra unidad centrak de ensayos clinicos 7a 2a fase
Pamplona Navarre, 31008, Spain
Hospital Universitario Sant Pau, Carrer de Sant Antoni Maria Claret, 167
Barcelona , 08025, Spain
Universitary Hospital La Princesa Calle de Diego de Leon 62
Madrid , 28006, Spain
Hospital Universitario Ramon y Cajal M-607, km 9.100
Madrid , 28034, Spain
Hospital 12 de Octubre Avda de Cordoba, s/n
Madrid , 28041, Spain
Hospital Universitario de Salamanca Paseo de San Vicente 58-182
Salamanca , 37007, Spain
The Royal Marsden Hospital Downs Road Surrey
London , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

282

Study ID:

NCT03761108

Recruitment Status:

Active, not recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.