Multiple Myeloma Clinical Trial
Official title:
Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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