This is a multi-centre Phase III randomized controlled study of patients with multiple myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment. Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed for the: 1. Incidence and grade of any toxicity 2. Level of maximum disease response 3. Time to disease progression 4. Time to death
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
100 mg/day continuously for 12 months
Melphalan 2 mg, Prednisolone 16 mg
Baskent University School of Medicine Education and Research Hospital, Hematology Department
Adana, Turkey (Türkiye)
Ankara Numune Education and Research Hospital,Hematology Department
Ankara, Turkey (Türkiye)
Ankara University School of Medicine, Hematology Department
Ankara, Turkey (Türkiye)
Gazi University School of Medicine, Hematology Department
Ankara, Turkey (Türkiye)
Hacettepe University School of Medicine, Hematology Department
Ankara, Turkey (Türkiye)
Akdeniz University School of Medicine , Hematology Department
Antalya, Turkey (Türkiye)
Uludag University School of Medicine, Hematology Department
Bursa, Turkey (Türkiye)
Osmangazi University School of Medicine , Hematology Department
Eskişehir, Turkey (Türkiye)
Marmara University School of Medicine, Hematology Department
Istanbul, Turkey (Türkiye)
response rate
Time frame: 12 months
time to relapse
Time frame: 18 months
overall survival
Time frame: unlimited
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