CA058-1019

About this trial

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).

The study will compare a new treatment called alnuctamab to the standard treatments. Alnuctamab is a type of medicine that may help the body’s immune system fight cancer cells. The goal of the study is to evaluate whether alnuctamab works better than the standard MM treatments and is safe for people with RRMM. Other goals include looking at how long participants live, how well the treatment works, how safe it is and how participants feel taking the treatment.

Patient Profile

Inclusion Criteria 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.

Where’s this trial being run?

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

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Questions

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Summary Data

Name:	CA058-1019
Number:	CA058-1019
Full Title:	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

Principal Investigator:	TBC
Type:	Industry Sponsored
Sponsor:	Bristol-Myers Squibb International Corporation
Recruitment Started:	Global: 29-Mar-2024 Ireland:

Global Recruitment Target:	466
Ireland Recruitment Target:	TBC