This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant. In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival. Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65. Patients will be evaluated at scheduled visits up to 3 periods of study: pretreatment, treatment and monitoring.
Patients included in the study will receive a 6 week cycle consisting of Bendamustine administered IV at doses of 90 mg/m2 on days 1 and 4 of the first cycle and days 1 and 8 in subsequent cycles in combination with Bortezomib as a bolus dose of 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32, and oral prednisone at doses of 60 mg/m2, during the first four days of each cycle. Then, patients will receive eight additional cycles of 5-week . The same pattern consisting of bendamustine and prednisone but bortezomib is administered as an intravenous bolus dose of 1.3 mg/m2 on days 1, 8, 15 and 22.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Institut català d'Oncología
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
MD Anderson Internacional
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Morales Messeguer
Murcia, Spain
...and 4 more locations
Efficacy in terms of response rate and complete response rate (CR and near CR)
Time frame: 1 year
Safety in terms of toxicity
Time frame: 1 year
Time to progresion
Time frame: 3 years
Progresion free survival
Time frame: 2 years
Global survival
Time frame: 3 years
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