A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

RetiradoFase 3ClinicalTrials.gov

ID: NCT06232707Tipo: INTERVENTIONALInicio: 3 de may de 2024Fin estimado: 21 de sept de 2030

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Resumen

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
Documented diagnosis of multiple myeloma (MM), and must:.
i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.
ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.
Must have measurable disease (as determined by central laboratory).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Criterios de exclusión

Active, uncontrolled, or suspected infection.
Known current, or history of, central nervous system involvement of multiple myeloma.
History or presence of clinically relevant CNS pathology.
Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.