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
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).
1 other identifier
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2003
Longer than P75 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedFebruary 18, 2010
February 1, 2010
February 17, 2010
February 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
Study Arms (6)
thalidomide + dexamethasone
EXPERIMENTALThalidomide 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
ACTIVE COMPARATORthalidomide, melphalan, endoxan, dexamethasone
EXPERIMENTALmelphalan, endoxan, dexamethasone (MCDex)
ACTIVE COMPARATORThalidomide, Dexamethasone
EXPERIMENTALwatch and wait
NO INTERVENTIONInterventions
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- Laphalcollaborator
Study Sites (3)
CHU CAEN Dept of Hematology
Caen, 14033, France
CHU Henri Mondor
Créteil, 94010, France
CHU Saint Louis Dept of Hematology
Paris, 75475, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
May 1, 2003
Study Completion
December 1, 2009
Last Updated
February 18, 2010
Record last verified: 2010-02