Multiple Myeloma Clinical Trial
Official title:
Randomized Phase II Study of Bortezomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Elderly Patients With Newly Diagnosed Multiple Myeloma
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 ;
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