Phase 2 efficacy study of CC-4047+dexamethasone in renal impairment
Research type
Research Study
Full title
A PHASE 2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF POMALIDOMIDE (CC-4047) IN COMBINATION WITH LOW DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND MODERATE OR SEVERE RENAL IMPAIRMENT INCLUDING SUBJECTS UNDERGOING HEMODIALYSIS
IRAS ID
136418
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2013-001903-36
Research summary
Patients that have been diagnosed with mutiple myeloma suffer from cancer of the plasma cells (these are immune cells that produce antibodies). This can be two types where the cancer returns after treatment (relapsed) or it has not responded to the most recent treatment (refractory). The kidneys often do not function effectively as a result of the myeloma
This study will examine how the new drug pomalidomide, in combination with low-dose dexamethasone works in patients with relapsed or refractory multiple myeloma (RRMM) and impaired kidney function. It will also test the safety of these drugs in patients with various degrees of kidney impairment. The purpose of the pharmacokinetic investigation is to verify how well patients tolerate the treatment and how the body absorbs it, distributes, breaks down and eliminates the study drug.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0699
Date of REC Opinion
8 Nov 2013
REC opinion
Further Information Favourable Opinion