Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies. (MAG 2002)

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma de Novo Treatment

Treatments: Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal); Drug: Thalidomide, Dexamethasone; Drug: Vincristin , Adriamycin, Dexamethasone = VAD; Drug: melphalan, endoxan, dexamethasone (MCDex)

Study type: Interventional

Funder types: Other

Identifiers

NCT01070862

020879

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

thalidomide + dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Thalidomide, Dexamethasone

Drug: Thalidomide, Dexamethasone

Vincristin, Adriamycin, Dexamethasone

Active Comparator group

Treatment:

Drug: Vincristin , Adriamycin, Dexamethasone = VAD

thalidomide, melphalan, endoxan, dexamethasone

Experimental group

Treatment:

Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)

melphalan, endoxan, dexamethasone (MCDex)

Active Comparator group

Treatment:

Drug: melphalan, endoxan, dexamethasone (MCDex)

Thalidomide, Dexamethasone

Experimental group

Treatment:

Drug: Thalidomide, Dexamethasone

Drug: Thalidomide, Dexamethasone

watch and wait

No Intervention group