Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure

Summary

Primary outcome measure: * Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment Secondary outcome measures: * Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle * 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

Timeline

Start

2010-03

Primary completion

2012-09

Completion

2013-12

Drugs

Indications