The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
130
Gruppo Italiano Studio Linfoma
Modena, Modena, Italy
To assess the efficacy
To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
Time frame: from 8 to 12 months
To assess the toxicity
To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0
Time frame: From 1 to 12 months
To evaluate the Overall Survival (OS) in the 2 arms of treatment
OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause
Time frame: From 1 to 60 months
To evaluate the Duration of Remission (DR) in the 2 arms of treatment
DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination
Time frame: From 8 to 60 months
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