Viewing Study NCT00065351



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00065351
Status: COMPLETED
Last Update Posted: 2019-11-12
First Post: 2003-07-21

Brief Title: Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Sponsor: Celgene
Organization: Celgene

Study Overview

Official Title: A Multicenter Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Status: COMPLETED
Status Verified Date: 2019-11
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: For each subject the study will consist of two phases a treatment phase and a follow-up phase Screening procedures will take place within 28 days of baseline

Treatment Phase Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter

Follow-Up Phase All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment
Detailed Description: None

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