Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
- Conditions
- Multiple Myeloma de Novo Treatment
- Interventions
- Registration Number
- NCT01070862
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.
- Detailed Description
MY-TAG : Thalidomide as induction treatment before high dose therapy, in young patients MY-DECT : Thalidomide as induction treatment with conventional chemotherapy, in elderly patients MY-PLAT : Thalidomide and Dexamethasone at plateau-phase, after high dose therapy or conventional chemotherapy
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- for MY-TAG(auto-transplant): age 18-65, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-DECT (conventional chemotherapy) : qge 66-80, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
- for MY-PLAT (maintenance at plateau-phase): patients treated in MY-TAG or MY-DECt with at least a minimal response (25 % decrease of M protein)3-6 months after autotransplant or last chemotherapy
- for MY-TAG : age 66 or more, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, anthracycline contra-indicated, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-DECT : age < 66 or > 80, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
- for MY-PLAT : no response or progressive disease, randomization > 6 m since autotransplant or last chemotherapy, creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description thalidomide + dexamethasone Thalidomide, Dexamethasone Thalidomide 200 mg/d at bedtime + Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle Vincristin, Adriamycin, Dexamethasone Vincristin , Adriamycin, Dexamethasone = VAD - thalidomide, melphalan, endoxan, dexamethasone Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) - melphalan, endoxan, dexamethasone (MCDex) melphalan, endoxan, dexamethasone (MCDex) - Thalidomide, Dexamethasone Thalidomide, Dexamethasone -
- Primary Outcome Measures
Name Time Method very good partial response rate (monclonal protein decrease of 90 % or more)at the end induction phase (MY-TAG and MY-DECT), progression free survival during consolidation/maintenance treatment (MY-PLAT) before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
- Secondary Outcome Measures
Name Time Method partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
Trial Locations
- Locations (3)
CHU Saint Louis Dept of Hematology
🇫🇷Paris, France
CHU CAEN Dept of Hematology
🇫🇷Caen, France
CHU Henri Mondor
🇫🇷Creteil, France