Phase 1b/2a Study to Evaluate CC-92480 (BMS-986348) in Combination with Other Treatments in RRMM

• Research type

  Research Study

• Full title

  An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study toAssess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480(BMS-986348) in Novel Therapeutic Combinations in Participants with Relapsed or RefractoryMultiple Myeloma

• IRAS ID

  1005265

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2021-005167-51

• Clinicaltrials.gov Identifier

  NCT05372354

• Research summary

  The purpose of this study is to test the safety (any good or bad effects) and to define the appropriate doses of an investigational drug (CC-92480) given in combination with dexamethasone and any one of the following drugs: tazemetostat, BMS-986158, or trametinib.

  CC-92480 is a medication taken by mouth that binds to a protein within you known as cereblon, resulting in the destruction of specific proteins by the body. This drug can modify or control the functioning of the immune system and trigger the destruction of proteins that are important to keep myeloma cells alive. This leads to the breakdown and death of the multiple myeloma cells. Dexamethasone is a synthetic (man-made) steroid taken by mouth or intravenously (IV) that is used in the treatment of multiple myeloma. Dexamethasone can cause a cell to destroy itself.

  Tazemetostat works by blocking a protein called EZH2. Blocking EZH2 helps increase the expression of genes that suppress the growth of cancer.
  BMS-986158 is a small molecule inhibitor of the BET family of bromodomain proteins and is taken by mouth. These proteins control the creation of cancer genes in different types of cancer cells. The BMS-986158 drug blocks the proteins from activating these cancer genes.

  The study has 2 parts, Dose Finding (Part 1) and Dose Expansion (Part 2). The goal of Part 1 is to determine the doses of each drug that can be administered safely to patients who have multiple myeloma.
  There are 4 periods on this study: Screening, Treatment, Safety Follow-up, and Efficacy Follow-up.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0118

• Date of REC Opinion

  6 Jul 2022

• REC opinion

  Further Information Favourable Opinion