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Pethema Multiple Myeloma 2000

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00560053
First received: November 15, 2007
Last updated: November 26, 2008
Last verified: November 2008
History of Changes

November 15, 2007
November 26, 2008
January 2000
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Complete list of historical versions of study NCT00560053 on ClinicalTrials.gov Archive Site
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Pethema Multiple Myeloma 2000
Multiple Myeloma 2000. Multicentric Evaluation of a Therapeutic Strategy Optimized in Multiple Myeloma. Analysis of Efficiency and Possible Pronostic Impact of Minimal Residual Disease (Measured By PCR And Citometry of Flow) in Patients With Complete Response

The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Alternating chemotherapy

    4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.

    VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20.

  • Procedure: Autologous Transplantation

    Autologous Transplantation :

    BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria

  • Drug: Maintenance

    At 3 months of transplantation or with >1.500 neutrophiles/ > 75.000 platelets mm 3 .

    Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse.

  • Procedure: Second transplantation
    In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
  • Procedure: ALOGENIC MINI TRASPLANTATION
    ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
February 2005
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Inclusion Criteria:

  • Less 70 years
  • ECOG 0-2
  • Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).
  • No previous chemotherapy

Exclusion Criteria:

  • >70 years
  • ECOG 3-4
  • myeloma quiescent
  • cardiopathy
  • liver disfunction
  • HIV+
  • Hepatitis B-C +
  • Previous chemotherapy
Both
up to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00560053
PETHEMA MM-2000
Yes
Not Provided
PETHEMA Foundation
Not Provided
Study Chair: Joan Bladé, Dr Hospital Clinic Barcelona
Study Chair: Juan Jose Lahuerta, Dr Hospital Doce de Octubre Madrid
Study Chair: Adrián Alegre, Dr Hospital La Princesa Madrid
Study Chair: Anna Sureda, Dr Hospital Sant Pau Barcelona
Study Chair: Joaquín Díaz Mediavilla, Dr Hospital Clinico Madrid
Study Chair: Javier De la Rubia, Dr Hospital La fe de Valencia
Study Chair: Joan Bargay, Dr Hospital Son Dureta Palma de Mallorca
Study Chair: Jose García-Laraña, Dr Hospital Universitario Ramon y Cajal
Study Chair: Eulogio Conde, Dr Hospital Valdecilla Santander
Study Chair: Felipe Prosper, Dr Hospital Clinico Valencia
PETHEMA Foundation
November 2008

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