This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids.
TREATMENT PERIOD: Arm A: Rd * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21. * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance. Arm B: Rd-R (reduced) * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21 * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles. Maintenance until progression or intolerance: \- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Fondazione EMN Italy Onlus
Torino, Italy
Event-free survival
Determine the Event-free survival defined as: * Progression * Death for any cause * Discontinuation of lenalidomide therapy * Occurrence of any haematological grade 4 or non-haematological grade 3-4 adverse events (AES), including Secondary Primary Malignancies (SPMs)
Time frame: 3 years
Progression-free survival (PFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Time to progression (TTP)
Time frame: 5 years
Overall response rate (ORR)
Time frame: 5 years
Time to response (TTR)
Time frame: 5 years
Duration of response (DOR)
Time frame: 5 years
Time to the next therapy (TNT)
Time frame: 5 years
Incidence of dose reduction and drug discontinuation
Time frame: 5 years
Health care cost
Time frame: 5 years
Correlation between tumor response and outcome with baseline prognostic factors
Analysis of tumor response and outcome stratification by prognostic factors
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Time frame: 5 years
Quality of life assessment (HRQOL)
Time frame: 5 years