Multiple Myeloma Clinical Trial

Phase 1/2 Study of REGN5458 in Adult 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, Part 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:

a. 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 b. 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 (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment.

Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria:

a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. 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.

Phase 2 (Cohorts 1 and 2):

Patients with MM whose disease meets the following criteria:

a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.

Phase 2 (Cohort 3):

Patients with MM whose disease meets the following criteria:

Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR

Patients must be triple- refractory, defined as being refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.

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

AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then:

• Treatment with a CAR-T must have been associated with a response of PR or better, and

• If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with REGN5458.

Key Exclusion Criteria:

1. 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) 2. Patients with known MM brain lesions or meningeal involvement -Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA) 3. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excludedand BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3.

4. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment

Note 1: Other protocol defined inclusion / exclusion criteria apply Note 2: US enrollment completed

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

387

Study ID:

NCT03761108

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 36 Locations for this study

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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 More Info
Ka Lung Wu, MD
Contact
+32 3 217 74 48
[email protected]
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium More Info
Marie-Christiane Vekemans, MD
Contact
+32-276-41872
[email protected]
Universitaetsklinikum Essen
Essen , 45147, Germany
University Medicine Mainz
Mainz , 55131, Germany
Universitatsklinikum Wurzburg
Würzburg , 6 970, Germany
Gunma University Hospital. 3-39-15 Showa-machi
Maebashi Gunma, 371-8, Japan More Info
Hiroshi Handa
Contact
+81-27-220-7111
Saitama Medical University International Medical Center. 1397-1 Oaza Yamane, Hidaka
Hidaka Saitama, 350-1, Japan More Info
Kunihiro Tsukasaki
Contact
+81-42-984-4111
[email protected]
Japanese Red Cross Medical Center. 4-1-22 Hiroo
Shibuya-ku Tokyo, 150-8, Japan More Info
Tadao Ishida
Contact
+81-3-3400-1311
Ibaraki Prefectural Central Hospital. 6528 Koibuchi, Kasama
Kasama , 309-1, Japan More Info
Mitsuo Hori
Contact
+81-296-77-1121
[email protected]
University Hospital Kyoto Prefectural University of Medicine. 465 Kajii-cho, Kawaramachi-Hirokoji,Kamigyo-ku
Kyoto , 602-8, Japan More Info
Junya Kuroda
Contact
+88-075-251-5111
[email protected]
Tokushima Prefectural Central Hospital. 1-10-3 Kuramoto-cho
Tokushima , 770-8, Japan More Info
Shuji Ozaki
Contact
+81-88-631-7151
[email protected]
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
Hyeon Seok Eom
Contact
82-31-920-2402
[email protected]
Soul National University Hospital Jongno-gu
Seoul , 03080, Korea, Republic of More Info
Ja Min Byun, MD
Contact
82220721477
[email protected]
Severance Hospital, Yonsei University Health System Seodaemun-gu
Seoul , 03722, Korea, Republic of More Info
Jin Seok Kim, MD
Contact
+82-2-2228-4242
[email protected]
Seoul St.Mary's Hospital, The Catholic University of Korea Seocho-gu
Seoul , 137-7, Korea, Republic of More Info
Chang Ki Min, MD
Contact
82-2-2258-6053
[email protected]
Clinica universidad de Navarra unidad centrak de ensayos clinicos 7a 2a fase
Pamplona Navarre, 31008, Spain More Info
Paula Rodriguez Otero
Contact
34-948-296397
Hospital Universitario Sant Pau, Carrer de Sant Antoni Maria Claret, 167
Barcelona , 08025, Spain More Info
Jordi Lopez Pardo, MD
Contact
+34 93 291 1293
[email protected]
Universitary Hospital La Princesa Calle de Diego de Leon 62
Madrid , 28006, Spain More Info
Adrian Alegre Amor
Contact
34-622-17584
Hospital Universitario Ramon y Cajal M-607, km 9.100
Madrid , 28034, Spain More Info
Maria Jesus Blanchard Rodriguez, MD
Contact
+34913368967
[email protected]
Hospital 12 de Octubre Avda de Cordoba, s/n
Madrid , 28041, Spain More Info
Joaquin Martinez Lopez, MD
Contact
+34 6303036921940
[email protected]
Hospital Universitario de Salamanca Paseo de San Vicente 58-182
Salamanca , 37007, Spain More Info
Maria Victoria Mateos Manteca, MD
Contact
34678438203
[email protected]
The Royal Marsden Hospital Downs Road Surrey
London , SM2 5, United Kingdom More Info
Martin Kaiser, MD
Contact
0208 661 3018
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

387

Study ID:

NCT03761108

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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