Pethema Multiple Myeloma 2000

Summary

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.

Conditions

• Multiple Myeloma

Interventions

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

Sponsors & Collaborators

• PETHEMA Foundation

  lead OTHER

Principal Investigators

• Joan Bladé, Dr · Hospital Clinic of Barcelona

• Juan Jose Lahuerta, Dr · Hospital Doce de Octubre Madrid

• Adrián Alegre, Dr · Hospital La Princesa Madrid

• Anna Sureda, Dr · Hospital Sant Pau Barcelona

• Joaquín Díaz Mediavilla, Dr · Hospital Clinico Madrid

• Javier De la Rubia, Dr · Hospital La Fe de Valencia

• Joan Bargay, Dr · Hospital Son Dureta Palma de Mallorca

• Jose García-Laraña, Dr · Hospital Universitario Ramon y Cajal

• Eulogio Conde, Dr · Hospital Valdecilla Santander

• Felipe Prosper, Dr · Hospital Clinico Valencia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-01-31

Completion

2005-02-28