Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma
This trial will include patients who are not candidates for transplantation and above the
age of 55. Treatment cycles will include (MP)melphalan (9 mg /sq.m/day d1-4), prednisolone
(60 mg/sq.m/d,d1-4) every six weeks for maximum 8 cycles. Patients will be randomised to
(MPT) Thalidomide (1:1) 100 mg/day continuously. Cross-over to MPT is allowed if
insufficient response is obtained in the MP arm. response will be evaluated every other
cycle. At the end of 12 months of treatment patients will be followed until progress and
death. Second line treatment is not defined.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate
12 months
No
Meral Beksac, Prof.Dr.
Principal Investigator
Ankara University
Turkey: Ministry of Health
TMSG-2005-001
NCT00934154
March 2006
September 2012
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