Clinical trial NCT01070862: Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma de Novo Treatment
Keywords: multiple myeloma, treatment, first line
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Laphal
First posted: 2010-02-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
Secondary outcomes:
measure: partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU CAEN Dept of Hematology
city: Creteil
country: France
facility: CHU Henri Mondor
city: Paris
country: France
facility: CHU Saint Louis Dept of Hematology
Study officials:
References: