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Sponsored by: |
Fundacion Para La Investigacion Hospital La Fe |
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Information provided by: | Fundacion Para La Investigacion Hospital La Fe |
ClinicalTrials.gov Identifier: | NCT00804947 |
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Intravenous busulfan and melphalan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intravenous busulfan and melphalan: Experimental |
Drug: Intravenous busulfan and melphalan
BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.
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Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100).
Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Javier de la Rubia, MD | 34963862746 | delarubia_jav@gva.es |
Contact: Guillermo Sanz, MD | 34963862746 | sanz_gui@gva.es |
Spain | |
H. 12 de Octubre | Recruiting |
Madrid, Spain | |
Contact: Juan J Lahuerta, MD jjlahuerta@terra.es | |
Principal Investigator: Juan J Lahuerta, MD | |
H La Princesa | Recruiting |
Madrid, Spain | |
Contact: Adrián Alegre, MD Adrian.Alegre@telefonica.net | |
Principal Investigator: Adrián Alegre, MD | |
S. de Hematología. Hospital La Fe | Recruiting |
Valencia, Spain, 46009 | |
Principal Investigator: Javier de la Rubia, MD | |
Sub-Investigator: Guillermo Sanz, MD | |
Sub-Investigator: Isidro Jarque, MD | |
Hospital Dr. Peset | Recruiting |
Valencia, Spain | |
Contact: Paz Ribas, MD ribas_paz@gva.es | |
Principal Investigator: Paz Ribas, MD | |
Hospital Clínico | Recruiting |
Valencia, Spain | |
Contact: Carlos Solano, MD carlos.solano@uv.es | |
Principal Investigator: Carlos Solano, MD | |
Spain, Las Palmas | |
Hospital Insular Canarias | Recruiting |
Las Palmas de Gran Canaria, Las Palmas, Spain | |
Contact: Juan D González, MD jdgonsan@gobiernodecanarias.org | |
Principal Investigator: Juan D González, MD |
Study Director: | Miguel A Sanz, MD | S: de Hematología. Hospital La Fe, Valencia. Spain |
Responsible Party: | Hematology Service. Hospital La Fe. Valencia, Spain ( Javier de la Rubia ) |
Study ID Numbers: | BuMel-MM |
Study First Received: | December 5, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00804947 |
Health Authority: | Spain: Ethics Committee |
Autologous transplantation Multiple Myeloma Intravenous Busulfan |
Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Busulfan Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Alkylating Agents |