Multiple Myeloma
Conditions
Interventions
Drug: REGN5458 administered by intravenous (IV) infusion
Phase 2: Until disease progression or other discontinuation criterion is met
Sponsors
Knorr Kate
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the phase 2 portion, the primary endpoint in the study for all phase 2 cohorts is: 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 Applicable to the Japan cohort only: - The incidence of DLTs from the first dose through the end of the DLT observation period in up to 8 Japanese patients - Concentrations of REGN5458 in serum over time in Japanese patients | — |
Secondary
| Measure | Time frame |
|---|---|
| In the phase 2 portion (for all phase 2 cohorts): - ORR according to IMWG criteria (Kumar, 2016) as determined by the investigator - DOR and PFS according to IMWG criteria (Kumar, 2016) and as determined by the IRC and the investigator - Rate of MRD negative status - OS - Evaluation of the effects of REGN5458 on patient-reported QoL, symptoms and functioning (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20]), and per EuroQoL-5 Dimension-3 Level Scale [EQ-5D-3L]) - Change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30 - Time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30 - Evaluation of the effects of REGN5458 on general health status (per EQ-5D-3L) patient-reported functions and symptoms (per EORTC QLQ-C30 and QLQ-MY20) - The incidence and severity of TEAEs and AESI with REGN5458 - Concentrations of REGN5458 in the serum over time - Incidence over time of treatment-emergent anti-drug antibodies (ADAs) to REGN5458 | — |
Countries
Belgium, Germany, Japan, Korea, Republic of, Spain, United Kingdom, United States
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed