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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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: Alternating chemotherapy
Procedure: Autologous Transplantation
Drug: Maintenance
Procedure: Second transplantation
Procedure: ALOGENIC MINI TRASPLANTATION
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by PETHEMA Foundation:

Enrollment: 500
Study Start Date: January 2000
Study Completion Date: February 2005
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560053

Sponsors and Collaborators
PETHEMA Foundation
Investigators
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
  More Information

Additional Information:
spanish hematology association  This link exits the ClinicalTrials.gov site

No publications provided by PETHEMA Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00560053     History of Changes
Other Study ID Numbers: PETHEMA MM-2000
Study First Received: November 15, 2007
Last Updated: November 26, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Multiple Myeloma
Alternating chemotherapy
Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm, Residual
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
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013