Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056160
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2003-03-06
Brief Title:
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Randomized Parallel-Group Double-blind Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles Each subject will participate in a treatment phase and a follow-up phase
Detailed Description:
This was a phase 3 multicenter double-blind placebo-controlled parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma Eligible subjects were randomized in a 11 ratio to 1 of 2 treatment groups Subjects in the CC-5013Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle Subjects in the PlaceboDex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4 9 to 12 and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy Beginning with Cycle 5 the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None