A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Withdrawn before enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT06232707

Run by

Celgene

People needed

0

Starts

2024-05-03

Expected to finish

2030-09-21

Last updated by the study team

2024-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0088 — Los Angeles, California, United States
• Local Institution - 0358 — Stanford, California, United States
• Local Institution - 0355 — New Haven, Connecticut, United States
• Local Institution - 0434 — Washington D.C., District of Columbia, United States
• Local Institution - 0433 — Wichita, Kansas, United States
• Local Institution - 0439 — Saint Matthews, Kentucky, United States
• Local Institution - 0323 — New Orleans, Louisiana, United States
• Local Institution - 0324 — Baltimore, Maryland, United States
• Local Institution - 0441 — Bethesda, Maryland, United States
• Local Institution - 0435 — Billings, Montana, United States
• Local Institution - 0157 — Hackensack, New Jersey, United States
• Local Institution - 0359 — Summit, New Jersey, United States
• Local Institution - 0430 — Lake Success, New York, United States
• Local Institution - 0396 — New York, New York, United States
• Local Institution - 0306 — Cincinnati, Ohio, United States
• Local Institution - 0199 — Cleveland, Ohio, United States
• Local Institution - 0437 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0352 — Providence, Rhode Island, United States
• Local Institution - 0420 — Watertown, South Dakota, United States
• Local Institution - 0168 — Dallas, Texas, United States
• Local Institution - 0405 — Seattle, Washington, United States
• Local Institution - 0001 — La Plata, Buenos Aires, Argentina
• Local Institution - 0262 — Pilar, Buenos Aires, Argentina
• Local Institution - 0222 — San Juan Bautista, Buenos Aires, Argentina
• Local Institution - 0151 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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