Multiple Myeloma Clinical Trial
Official title:
A National, Multicentric, Open-label Study of Induction Treatment With VELCADE and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure
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
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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