Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Alternating chemotherapy, Transplantation
Brief 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.
Interventions
DRUGAlternating 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.
PROCEDUREAutologous 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
DRUGMaintenance
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.
PROCEDURESecond transplantation
In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
PROCEDUREALOGENIC 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
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 69 Years
Healthy volunteers
No
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
Outcome results
None listed