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A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00051116
First received: January 3, 2003
Last updated: September 22, 2009
Last verified: September 2009

January 3, 2003
September 22, 2009
May 2002
October 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00051116 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma
A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: CC-5013
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2006
October 2006   (final data collection date for primary outcome measure)
  • History of histologically documented multiple myeloma with relapsed or resistant disease
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051116
CC-5013-MM-008
No
Robert Knight MD - VP Hematology, Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Robert Knight, MD Celgene Corporation
Celgene Corporation
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP