Phase 1/2 Study of REGN5458 in Patients with Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2031230025
- Lead Sponsor
- Houvras Yariv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 18
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 2:
-Progression on or after at least 3 prior lines of therapy including a(n) protease inhibitor (PI), immunomodulatory agent (IMiD), and anti-cluster of differentiation 38 (CD38) antibody, OR
- 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. Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or less than 25% response to therapy.
- Other protocol defined inclusion criteria apply
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Patients with known MM brain lesions or meningeal involvement
- Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA)
- 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
- Other protocol defined exclusion criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In the phase 2 portion, the primary endpoint in the study for all phase 2 cohorts is:<br>ORR as determined by blinded IRC, as measured using the IMWG criteria, in patients who have progressed on or after 3 prior lines of therapy or who are triple-refractory<br><br>Applicable to the Japan cohort only:<br>- The incidence of DLTs from the first dose through the end of the DLT observation period in up to 8 Japanese patients<br>- Concentrations of REGN5458 in serum over time in Japanese patients
- Secondary Outcome Measures
Name Time Method