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Trial record 94 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

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

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 18, 2010
Last Update Posted Date February 18, 2010
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
Official Title  ICMJE 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).
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma de Novo Treatment
Intervention  ICMJE
  • Drug: Thalidomide, Dexamethasone
    Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
  • 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
  • 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
  • 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
  • Drug: Thalidomide, Dexamethasone
    Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
Study Arms  ICMJE
  • 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
    Intervention: Drug: Thalidomide, Dexamethasone
  • Active Comparator: Vincristin, Adriamycin, Dexamethasone
    Intervention: Drug: Vincristin , Adriamycin, Dexamethasone = VAD
  • Experimental: thalidomide, melphalan, endoxan, dexamethasone
    Intervention: Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)
  • Active Comparator: melphalan, endoxan, dexamethasone (MCDex)
    Intervention: Drug: melphalan, endoxan, dexamethasone (MCDex)
  • Experimental: Thalidomide, Dexamethasone
    Intervention: Drug: Thalidomide, Dexamethasone
  • No Intervention: watch and wait
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01070862
Other Study ID Numbers  ICMJE 020879
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret MACRO, MD, University hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Laphal
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP