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Primary outcome measure:
- Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment
Secondary outcome measures:
- Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib
- Reversibility of renal failure
- Predictive value in the light chain determination for response and reversibility of renal failure
- Early morbidity (< 2 months)
- Progression-free survival
- Overall survival
The safety outcome consists in:
- Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events
60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included.
It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure.
The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks.
Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle.
Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hospital Germans Trias i Pujol
Not yet recruiting
Published on BioPortfolio: 2014-07-23T21:09:52-0400
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