Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00540644|
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: lenalidomide (Revlimid®) Drug: Cyclophosphamide Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||August 2014|
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®
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
50 mg p.o. Q.O.D.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540644
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Attaya Suvannasankha, M.D.||Indiana University School of Medicine|