CA058-1019 (ALUMMINATE RRMM) Phase 3 Study of Alnuctamab in RRMM

• Research type

  Research Study

• 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

• IRAS ID

  1009047

• Contact name

  GSM-CT Representative

• Contact email

  clinical.trials@bms.com

• Sponsor organisation

  Celgene International II S.a.r.l.

• Clinicaltrials.gov Identifier

  NCT06232707

• Research summary

  This is a Phase 3 multicentre study of investigational drug, alnuctamab, in participants 18 years or older with relapsed or refractory multiple myeloma (RRMM). This study will compare alnuctamab with the following treatment regimens: daratumumab, pomalidomide, dexamethasone (DPd);OR elotuzumab, pomalidomide, dexamethasone (EPd) OR carfilzomib, dexamethasone (Kd).
  Alnuctamab is a medication that works in several ways to help the body’s defence system cause the breakdown of cancer cells. Alnuctamab is given by injection beneath the skin.
  Alnuctamab is a new medication not yet approved. DPd, EPd and Kd are approved treatments in the UK and other countries. Kd is a treatment available within the National Health Service (NHS) to treat RRMM in the UK.
  466 participants will take part in this study world-wide, 26 in the UK. Participants and their hospital doctor will know what treatment they are on.
  During the study, participants will have the following procedures: physical exams, heart scan (MUGA), body scans (PET CT/CT/MRI), bone marrow aspirations/biopsies, ECG, vital signs (blood pressure, breathing rate, heart rate and temperature), nasal swab, blood and urine sampling and pregnancy testing. Participants will receive study drug until they withdraw their consent, or no longer tolerate the study drug, or their disease worsens. Participants will have a follow-up visit in clinic 28 days and 80 days after their last dose. Long-term follow-up (remotely) will be every 28 days in clinic until disease worsens then every 4 months for survival and information on other MM treatment participants are taking.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  23/LO/0961

• Date of REC Opinion

  7 Feb 2024

• REC opinion

  Further Information Favourable Opinion