CC-92480 with Dexamethasone in Relapsed & Refractory Multiple Myeloma
Research type
Research Study
Full title
A Phase 1 Multicenter, Open-Label Study to Assess The Safety, Pharmacokinetics And Preliminary Efficacy of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed And Refractory Multiple Myeloma
IRAS ID
235714
Contact name
Karthik Ramasamy
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2017-001236-19
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Myeloma remains an incurable cancer. Myeloma patients undergo a sequence of treatments and eventually the cells become resistant to available medications. There is an urgent need to develop new treatments in myeloma as a majority of patients die due to their illness. This clinical trial will evaluate a new medication developed to combat myeloma. This medication has been developed with both information of how the available myeloma drug works, and how cells become resistant to current medications. This medication demonstrates ability to kill myeloma cells in disease models tested in the laboratory. The activity of this medicine is sufficiently convincing from these experiments to explore the activity of these drugs in relapsed myeloma patients. This trial is conducted to determine the dose that can be safely tolerated using 2 different dosing schedules in the treatment of relapsed myeloma patients. Patients who have myeloma and have had a number of previous treatments, and now require further therapy will be eligible for this study. The medication is given in tablet form either once a day or twice a day with steroid tablets. Gradually the dose of the medication will be increased provided no unacceptable side effects are observed. Occasionally patients will have to stay overnight to enable us to take blood samples. Blood samples will be taken to understand the levels of drugs in the body, effects of drug on myeloma as well as rest of the bone marrow. This study will be conducted in hospitals experienced in dealing with myeloma patients, as well as performing trials where new drugs are tested in myeloma patients. The study will be open for between one and 2 years in each of these trial centers. Once a patient signs up for the study on average they could expect to stay on the trial treatment for a period of 6 months. During this period standard assessments in the form of blood, urine and bone marrow tests will be taken. Patients will be observed for side effects and appropriate treatments will be given to address them. If the drug does demonstrate good response in a patient, they will be allowed to continue on these tablets until the drug ceases to be effective. If the drug is not tolerated by a patient or their myeloma continues to grow despite this treatment, they will come off this trial.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0028
Date of REC Opinion
31 Jan 2018
REC opinion
Favourable Opinion