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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)

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ClinicalTrials.gov Identifier: NCT01070862
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 18, 2010
Sponsor:
Collaborator:
Laphal
Information provided by:
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma de Novo Treatment Drug: Thalidomide, Dexamethasone Drug: Vincristin , Adriamycin, Dexamethasone = VAD Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) Drug: melphalan, endoxan, dexamethasone (MCDex) Phase 3

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2003
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

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

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 on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94

No Intervention: watch and wait



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

Secondary Outcome Measures :
  1. partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070862


Locations
France
CHU CAEN Dept of Hematology
Caen, France, 14033
CHU Henri Mondor
Creteil, France, 94010
CHU Saint Louis Dept of Hematology
Paris, France, 75475
Sponsors and Collaborators
University Hospital, Caen
Laphal

Responsible Party: Margaret MACRO, MD, University hospital, Caen
ClinicalTrials.gov Identifier: NCT01070862     History of Changes
Other Study ID Numbers: 020879
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010

Keywords provided by University Hospital, Caen:
multiple myeloma, treatment, first line

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Liposomal doxorubicin
Melphalan
Thalidomide
Doxorubicin
Cyclophosphamide
Vincristine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids