Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma
This study is enrolling participants by invitation only.
Karolinska University Hospital
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital
First received: September 7, 2011
Last updated: October 9, 2011
Last verified: October 2011
- A prospective, randomized, open, phase II, multi-centre, interventional study. Patients who are in at least PR and have received lenalidomide as 2nd line treatment for MM will be recruited.
- The patients will be randomized into two groups. Group R will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two consolidating cycles per patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate LenalidomideU.S. FDA Resources
Further study details as provided by Karolinska University Hospital:
Primary Outcome Measures:
- Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 years ] [ Designated as safety issue: Yes ]Number of Participants with Adverse Events
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .
|No Intervention: Revlimid and dexamethasone|
Contacts and Locations