CC-220-MM-001_Phase 1B/2A_Multiple Myeloma_CC-220
Research type
Research Study
Full title
A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of CC-220 Monotherapy and in Combination with Other Treatments in Subjects with Relapsed and Refractory Multiple Myeloma
IRAS ID
205953
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2016-000860-40
Duration of Study in the UK
4 years, 5 months, 16 days
Research summary
This is a phase 1B and 2A, open-label study to determine the highest tolerated dose of CC-220 when administered alone and the highest tolerated dose of CC-220 when it is administered in combination with another drug, dexamethasone. The study will also investigate whether CC-220 is safe and effective when treating symptoms related to relapsed (illness has come back) and refractory (unresponsive to treatment) multiple myeloma (MM).
MM remains an incurable neoplastic (abnormal growth) disease that accounts for 12% of all haematological malignancies (cancer of one or more of the components of blood). It has been estimated that 114,000 new cases and 80,000 deaths from MM occurred globally in 2012. MM remains incurable using conventional treatments, with an overall 5-year relative survival rate of 45%. Therefore new therapies are needed to treat relapsed and refractory MM.
The study is open to adults 18 years of age or older who have relapsed or refractory MM.
CC-220 is a drug given by mouth that belongs to a group of drugs known as immunomodulatory compounds.CC-220 has demonstrated anti-tumour activity in multiple myeloma cell lines. This study will be the first time CC-220 will be tested in patients with multiple myeloma.
The other study treatment Dexamethasone which is being investigated in combination with CC-220 is already approved for the treatment of MM.Dexamethasone in combination with CC220 is experimental.
About 106 patients in North America and Europe will take part in this research study. Patients may continue study treatment until their multiple myeloma progresses, they experience side effects that would require discontinuation of CC-220 or if they choose to withdraw from the study.
There will be several procedures performed in this study some include, ECG (a recording of your hearts electrical activity), bone marrow aspiration/biopsy (bone marrow will be drawn with a needle, x-ray, CT scan and MRI scan.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0159
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion