Status and phase
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Primary outcome measure:
Secondary outcome measures:
The safety outcome consists in:
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
The patient must, according with investigator criteria, be able to comply with all the protocol requirements
The patient or legal representative must sign voluntarily the informed consent before the performance of any study related procedure, not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care
18 years and older
Patients with newly diagnosed symptomatic multiple myeloma43 which hasn't been treated previously with any chemotherapy used for this disease (see Annex 8)
Patient with a measurable or evaluable disease, defined as follows:
ECOG performance status ≤ 2 (see Appendix 5)
Patient has a life-expectancy >3 months
Glomerular filtration calculated with MDRD <50 ml/min
Patient has the following laboratory values during the 14 days before first dose:
Exclusion criteria
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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