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)

February 17, 2010 updated by: University Hospital, Caen

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • CHU CAEN Dept of Hematology
      • Creteil, France, 94010
        • Chu Henri Mondor
      • Paris, France, 75475
        • CHU Saint Louis Dept of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: thalidomide + dexamethasone
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
Drug: Thalidomide, Dexamethasone
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
Drug: Thalidomide, Dexamethasone
Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
ACTIVE_COMPARATOR: Vincristin, Adriamycin, Dexamethasone
Drug: Vincristin , 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
EXPERIMENTAL: thalidomide, melphalan, endoxan, dexamethasone
Drug: Thalidomide, 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
ACTIVE_COMPARATOR: melphalan, endoxan, dexamethasone (MCDex)
Drug: melphalan, 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
EXPERIMENTAL: Thalidomide, Dexamethasone
Drug: Thalidomide, Dexamethasone
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
Drug: Thalidomide, Dexamethasone
Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
NO_INTERVENTION: watch and wait

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)
before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT)

Secondary Outcome Measures

Outcome Measure
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Laphal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (ESTIMATE)

February 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2010

Last Update Submitted That Met QC Criteria

February 17, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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