To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly frail patients with newly diagnosed multiple myeloma.
Group 1: 1 cycle will be repeated every 4 weeks 1. Bortezomib 1.3mg/m2 SC D1, 8, 15 \- Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15 2. Lenalidomide 25mg/d D1-21 \- Dose adjustment for more than 75 : 15mg/d D1-21 3. Dexamethasone 40mg D1, 8, 15, 22 * Dose adjustment for more than 75 years old: 20mg * If it is difficult to maintain bortezomib due to unacceptable toxicity, it can early discontinue from Group 1. \<for patients with old age or frail\> 1. Bortezomib 1.0mg/m2 SC D1, 8, 15 : Dose adjustment for more than 85 : 1.0mg/m2 SC D1,8,15 2. Lenalidomide 15mg/d D1-21 3. Dexamethasone 20mg D1, 8, 15, 22 Group 2: 1 cycle will be repeated every 4 weeks 1. Lenalidomide 25mg/d D1-21 - Dose adjustment for more than 75: 15mg 2. Dexamethasone 40mg D1, 8, 15, 22 - Dose adjustment for more than 75: 20mg \<for patients with old age or frail\> 1\) Lenalidomide 15mg/d D1-21 2) Dexamethasone 20mg D1, 8, 15, 22
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Bortezomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone
Samsung Medical Center
Seoul, South Korea
3-Year Progression-free survival (PFS)
The time from randomization into the date of first observation of documented disease progression or death.
Time frame: 3-years after randomization
Assessment of response
Response will be determined by the International Myeloma Working Group Response Criteria every cycle
Time frame: accessed every each cycle (each cycle is 28days)
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