This protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is also designed to compare the safety and efficacy (in terms of duration of response) of two maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment arm will include 100 patients and assessments and scheduled visits will be conducted in three periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring all adverse events, physical examination, vital signs and biochemical studies. Response to treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles of induction therapy and monthly during the first year of maintenance therapy and every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Cyclophosphamide - 50mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally(two pulses the first two cycles in days 1-4 and 15-18 and then a single pulse in each other cycle) during 9 cycles of 28 days.
Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally, in three pulses (days 1 to 4, 9 to 12 and 17 20) odd cycles and a single pulse treatment in pairs cycles, during 9 cycles of 28 days each cycle
thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle; melphalan - 4 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle; prednisone - 40 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
Response rate
Response rate is evaluated between the 3 treatment arms
Time frame: 36 months
Duration of response
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
Time frame: 36 months
overall survival
Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.
Time frame: 36 months
event-free survival
Event-free survival was defined as the interval from randomization to any event (death or descontinuation due to protocol violation or non-acceptable toxicities)
Time frame: 36 months
progression free-survival
Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
Time frame: 36 months
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