Pethema Multiple Myeloma 2000

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Alternating chemotherapy
* Procedure: Autologous Transplantation
* Drug: Maintenance
* Procedure: Second transplantation
* Procedure: ALOGENIC MINI TRASPLANTATION


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Alternating chemotherapy, Transplantation