CA057-008: Phase 3 Two-Stage Randomized Multi-centre Open-Label Study Comparing 480Kd vs Kd in RRMM

• Research type

  Research Study

• Full title

  A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

• IRAS ID

  1006170

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Celgene Corporation

• Clinicaltrials.gov Identifier

  NCT05552976

• Research summary

  This is a Phase 3 multicentre study of investigational drug CC-92480 in participants patients ≥18 years with relapsed or refractory multiple myeloma (RRMM).
  This study will compare treatment regimen CC-92480, Carfilzomib and Dexamethasone (480Kd) with Carfilzomib and Dexamethasone (Kd).
  CC-92480 is an oral drug that modulates modifies the immune system and causes the breakdown of cancer cells. It is a new drug and is not yet approved. Carfilzomib and dexamethasone are approved drugs commonly used in multiple myeloma. Carfilzomib is given intravenously (into a vein) and dexamethasone is a steroid taken by mouth or given into a vein.
  At least 525 patients will take part in this world-wide study, 19 in the UK. Participants Patients and doctors will know what treatment they are on.
  The study has 2 stages.
  In stage 1, three different dose levels of CC-92480 will be tested in the 480Kd treatment regimen. Approximately 128 participants will take part in stage 1.
  In stage 2, one of the three dose levels of CC-92480 from stage 1 will be selected for further testing. The 480Kd treatment regimen will be compared to with the Kd treatment regimen to further evaluate the safety and see if it is effective in 397 patients.
  During the study, participants will have the following procedures: physical exams, ECG, vital signs (blood pressure, heart rate and temperature), blood & urine sampling, pregnancy testing, radiological assessments (CT/MRI), and bone marrow sampling (which may include biopsies) and questionnaires (stage 2). Participants Patients will continue receiving study drugs until they withdraw their consent, no longer tolerate the study drugs, or their disease worsens. Participants will have a follow-up visit about 28 days from last dose. Long-term follow-up will be every 4 months by phone for at least 5 years or until death, lost to follow-up, or the end of the trial.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  22/EE/0227

• Date of REC Opinion

  29 Dec 2022

• REC opinion

  Further Information Favourable Opinion