Multiple Myeloma de Novo Treatment
Conditions
Keywords
multiple myeloma, treatment, first line
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
Interventions
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
DRUGVincristin , Adriamycin, Dexamethasone = VAD
Vincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle
DRUGThalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)
Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
DRUGmelphalan, endoxan, dexamethasone (MCDex)
melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
Sponsors
Laphal
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy | — |
Countries
France
Outcome results
None listed