This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003
Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell, called plasmatic cell. It represents the second most common haematological neoplasia, after Non Hodgkin Lymphoma. The annual incidence is over 4 cases per 100.000. Multiple Myeloma is an invariably mortal disease. When illness advances, the reduction of infections resistance, the intense bones destruction (with bone pain, pathological fractures and hypercalcemia), anaemia, renal failure and, in a less frequency, neurological complications and hyperviscosity provoke severe morbidity and mortality. Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29%. There is an urgent need of new therapeutic agents for the treatment of this disease
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)
Hospital Clínic
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Determinate the efficacy of combination velcade, melphalan, prednisone
Time frame: 1 year
Assess safety and tolerability
Time frame: 1 year
Assess potential superiority of this regimen versus historical controls with melphalan and prednisone alone
Time frame: 2 years
Evaluate efficacy in terms of progression-free survival and overall survival
Time frame: 5 years
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Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Hospital Morales Messeguer
Murcia, Murcia, Spain
...and 9 more locations