This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Irccs Crob
Rionero in Vulture, Potenza, Italy
Time to Progression
Time frame: 5 years
Survival
Overall Survival Progression Free Survival
Time frame: 5 years
Response
Objective overall response rate (ORR)
Time frame: 5 years
Response
Duration of response
Time frame: 5 years
Response
Time to response
Time frame: 5 years
Response
Time to the next anti-myeloma therapy (TNT)
Time frame: 5 years
Response
TTP measured from the beginning of the salvage treatment
Time frame: 5 years
Response
Role of the type of salvage treatment
Time frame: 5 years
Response
Role of previous treatments
Time frame: 5 years
Response
Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs)
Time frame: 5 years
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Response
Exploratory assessment on prognosis (ISS, age and FISH abnormalities)
Time frame: 5 years