A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
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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.
To assess the efficacy [ Time Frame: from 8 to 12 months ]
To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
To assess the toxicity [ Time Frame: From 1 to 12 months ]
To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0
Secondary Outcome Measures
To evaluate the Overall Survival (OS) in the 2 arms of treatment [ Time Frame: From 1 to 60 months ]
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
To evaluate the Duration of Remission (DR) in the 2 arms of treatment [ Time Frame: From 8 to 60 months ]
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
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Ages Eligible for Study:
65 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
newly diagnosed of multiple myeloma.
Age > 65 years
ECOG <= 3
Written informed consent given at the time of randomization
Patients with age <= 65 but not eligible for high dose treatment with stem cells support