search
Back to results

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)

Primary Purpose

Multiple Myeloma de Novo Treatment

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Thalidomide, Dexamethasone
Vincristin , Adriamycin, Dexamethasone = VAD
Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)
melphalan, endoxan, dexamethasone (MCDex)
Thalidomide, Dexamethasone
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma de Novo Treatment focused on measuring multiple myeloma, treatment, first line

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU CAEN Dept of Hematology
  • CHU Henri Mondor
  • CHU Saint Louis Dept of Hematology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

thalidomide + dexamethasone

Vincristin, Adriamycin, Dexamethasone

thalidomide, melphalan, endoxan, dexamethasone

melphalan, endoxan, dexamethasone (MCDex)

Thalidomide, Dexamethasone

watch and wait

Arm 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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2010
Last Updated
February 17, 2010
Sponsor
University Hospital, Caen
Collaborators
Laphal
search

1. Study Identification

Unique Protocol Identification Number
NCT01070862
Brief Title
Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
Acronym
MAG 2002
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen
Collaborators
Laphal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma de Novo Treatment
Keywords
multiple myeloma, treatment, first line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
thalidomide + dexamethasone
Arm Type
Experimental
Arm 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
Arm Title
Vincristin, Adriamycin, Dexamethasone
Arm Type
Active Comparator
Arm Title
thalidomide, melphalan, endoxan, dexamethasone
Arm Type
Experimental
Arm Title
melphalan, endoxan, dexamethasone (MCDex)
Arm Type
Active Comparator
Arm Title
Thalidomide, Dexamethasone
Arm Type
Experimental
Arm Title
watch and wait
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Dexamethasone
Intervention Description
Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
Intervention Type
Drug
Intervention Name(s)
Vincristin , Adriamycin, Dexamethasone = VAD
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
melphalan, endoxan, dexamethasone (MCDex)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Dexamethasone
Intervention Description
Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU CAEN Dept of Hematology
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Saint Louis Dept of Hematology
City
Paris
ZIP/Postal Code
75475
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs