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| Sponsored by: |
PETHEMA Foundation |
|---|---|
| Information provided by: | PETHEMA Foundation |
| ClinicalTrials.gov Identifier: | NCT00560053 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| 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 |
| Enrollment: | 500 |
| Study Start Date: | January 2000 |
| Study Completion Date: | February 2005 |
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.
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
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.
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 ramón y Cajal Madrid |
| Study Chair: | Eulogio Conde, Dr | Hospital Valdecilla Santander |
| Study Chair: | Felipe Prosper, Dr | Hospital Clinico Valencia |
More Information
| Study ID Numbers: | PETHEMA MM-2000 |
| Study First Received: | November 15, 2007 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00560053 |
| Health Authority: | Spain: Ministry of Health |
|
Multiple Myeloma Alternating chemotherapy Transplantation |
|
Neoplasm, Residual Dexamethasone Prednisone Melphalan Blood Protein Disorders Paraproteinemias Cyclophosphamide Hemostatic Disorders Hemorrhagic Disorders Multiple myeloma Dexamethasone acetate Interferon-alpha Immunoproliferative Disorders |
Hematologic Diseases Blood Coagulation Disorders Interferons Vascular Diseases Fludarabine monophosphate Doxorubicin Multiple Myeloma Busulfan Fludarabine Lymphoproliferative Disorders Interferon Alfa-2a Interferon Alfa-2b Neoplasms, Plasma Cell |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |
