The purpose of this study is to evaluate efficacy and safety of the combination regimen of bortezomib-bendamustine-dexamethasone in patients with relapsed or refractory multiple myeloma
After relapse after or early progression on first-line treatment the prognosis of multiple myeloma patients is unfavourable, with no remaining chance for cure. Therefore the search for new treatment regimens, including drugs with novel, and different, mechanisms of action is mandatory. Both bendamustine and bortezomib are not yet established parts of standard first-line regimens, but showed to have high activity both in chemo-naïve and pre-treated patients. The novel mechanism of action of the proteasome inhibitor and the non-cross resistance of bendamustine to other alkylating agents established in the first-line treatment of multiple myeloma seem to recommend a combination of the two drugs for salvage therapy. The promising response data in a series of relapsing MM patients treated with bendamustine, bortezomib and prednisone support this assumption, as well as the feasibility and tolerability of the combination. In summary, there is some evidence for a favourable risk/benefit ratio for the combination of bendamustine, bortezomib and a glucocorticoid drug, warranting the exploration in a larger, prospectively designed multicenter phase II study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Bendamustine 70 mg/m2 on days 1+4 Velcade 1.3 mg/m2 on days 1,4,8,11 Dexamethasone 20 mg on days 1,4,8 and 11 Repeated every 4 weeks
Medical University Hospital Graz
Graz, Austria
Hospital Elisabethinen Linz
Linz, Austria
LKH Salzburg, 3rd Med. Dept.
Salzburg, Austria
Med. University Vienna, Clinic for Internal Medicine 1 (Hematology and Hemostaseology)
Vienna, Austria
efficacy
evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)
Time frame: 8 cycles à 28 days plus follow-up phase
efficacy and safety
assessment of progression-free survival, overall survival, time to maximum response and toxicity
Time frame: 8 cycles à 28 days plus follow-up phase
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Hanusch Hospital Vienna
Vienna, Austria
Wilhelminenspital Vienna
Vienna, Austria
Clinic Wels-Grieskirchen, 4th Internal Dept.
Wels, Austria
Faculty Hospital Brno
Brno, Czechia