Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
|Multiple Myeloma||Drug: lenalidomide (Revlimid®) Drug: Cyclophosphamide Drug: Prednisone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma|
- Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria [ Time Frame: After 6 cycles ]Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
- Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: Beginning of treatment up to 5 years ]Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
- Quality of Life Using the FACT-G Data [ Time Frame: baseline and after last cycle (up to 6 cycles) ]
Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.
Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome
|Study Start Date:||October 2007|
|Study Completion Date:||August 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Revlimid, Cyclophosphamide, Prednisone
Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Prednisone every other day orally.
Drug: lenalidomide (Revlimid®)
25 mg p.o. daily on days 1-21 of each 28 day cycle
Other Name: Revlimid®Drug: Cyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycleDrug: Prednisone
50 mg p.o. Q.O.D.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540644
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Attaya Suvannasankha, M.D.||Indiana University School of Medicine|