Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

back

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

Status

Active

Cancer Type

Multiple Myeloma

Trial Phase

Phase I
Phase II

Eligibility

18 Years and older, Male and Female

Study Type

Treatment

NCT ID

NCT03761108

Protocol IDs

R5458-ONC-1826 (primary)
NCI-2019-02952
2018-003188-78

Study Sponsor

Regeneron Pharmaceuticals, Inc.

NCI Full Details

http://clinicaltrials.gov/show/NCT03761108

Summary

The main purpose of this study is to learn about the safety of REGN5458 and to find out
what is the best dose of REGN5458 to give to patients with multiple myeloma. An
additional purpose is to look for any signs that REGN5458 can treat cancer.

The study is looking at several other research questions, including:

- Side effects that may be experienced by people receiving REGN5458

- How REGN5458 works in the body

- How much REGN5458 is present in the blood

- How REGN5458 may work to treat cancer

Eligibility

Eastern Cooperative Oncology Group (ECOG) performance status â?¤ 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: â?¢ Treatment with a CAR-T must have been associated with a response of PR or better, and â?¢ 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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.

About Us Research Resources & Education Screening & Genetics Clinical Trials & Providers Cancer Navigators Survivorship Media, News & Events Contact Us Donate Take Our Survey Link to Us

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.

Georgia's Online Cancer Information Center

Find A Clinical Trial