A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.

This study aims to document the rate of renal response and reversal of renal impairment secondary to untreated multiple myeloma (MM) following treatment with Bortezomib and Dexamethasone. This will be done by blood analysis. Patients with untreated multiple myeloma will be selected by physicians. To ensure eligibility to go on trial the patients are required to undergo various blood tests, bone marrow aspirate ad doctor's review before commencing on this treatment. Who is it for? You may be eligible for this study if you are 18 years and over, have renal impairment secondary to MM, defined as a calculated estimated GFR <50ml/min. You must also provide written informed consent prior to the start of study-related procedures. Further details as to whether you are eligible for this study can be found in the inclusion and exclusion criteria within this trial record. Trial details Once you are deemed eligible to take part in this study, you will commence a 21 day cycle of Bortezomib 1.3mg/m2 IV given on days 1, 4, 8, and 11 and Dexamethasone 20mg oral on days 2, 4, 5, 8, 9, 11 and 12 on a 21 day cycle. If your disease does not achieve at least a partial remission after 2 cycles of therapy or shows disease progression at any time, you will be withdrawn from the trial. If you are eligible for high-dose chemotherapy conditioned stem cell transplant and have been responding to therapy, you will receive 4 cycles of therapy before proceeding to your transplant. If you are not eligible for a transplant, you will receive a maximum of 11 cycles of therapy except if you complete remission sooner, in which case you will have Bortezomib therapy ceased after two further cycles and therefore may receive less than 11 cycles of therapy. Treatment efficacy will be monitored throughout the study, at the end of each cycle and at the discretion of your treating doctors.