Pomalidomide in Relapsed or Refractory Multiple Myeloma Patients-MM007
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA
IRAS ID
172123
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2014-000268-17
Duration of Study in the UK
7 years, 1 months, 27 days
Research summary
Multiple Myeloma is a rare incurable cancer of plasma cells (type of white blood cells in the bone marrow). The cause of the disease is unknown. Multiple Myeloma affects about 4,700 people in the UK each year. Most cases occur in people aged 50 and older, and very rarely in younger adults.
The sponsor of this study, Celgene, wishes to further study their developed drug Pomalidomide in combination with Bortezomib and a low dose of the drug Dexamethasone (DEX) (Arm A) comparing it to Bortezomib and low dose Dexamethasone only (Arm B), in patients who suffer from Multiple Myeloma, and who’s disease has worsened after initial treatment, or has returned and worsened.
This is an expansion study from a study currently open in the United States. It is planned to randomise 782 subjects globally into the study by April 2017. The follow follow up phase can last up to 5 years.
Patients will be randomised in a 1:1 ratio to either receive either Arm A or Arm B:
Treatement arm A will consist of pomalidomide {Oral POM}, bortezomib {BTZ}, and dexamethasone {Oral DEX}.
Treatment arm B will consist of bortezomib {BTZ}, and dexamethasone {Oral DEX}.Study procedures for all the participants will be: Bone marrow aspiration, 12-lead electrocardiograms, physical exam, vital signs, blood hematology, chemistry tests, C-reactive protein, creatinine kinase, kidney function test, urinalysis, Pregnancy Counselling (both male and female); pregnancy testing for females of child bearing potential and radiological assessments
Patients will receive treatment as long as they benefit from the study drug or do not suffer severe side effects.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0443
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion