Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).
18 Years
80 Years
Both
Multiple Myeloma de Novo Treatment
Trial Information
Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Time Frame:
before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
Safety Issue:
Yes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
020879
NCT ID:
NCT01070862
Start Date:
May 2003
Completion Date:
December 2009
Related Keywords:
- Multiple Myeloma de Novo Treatment
- multiple myeloma, treatment, first line
- Multiple Myeloma
- Neoplasms, Plasma Cell
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