Multiple Myeloma Clinical Trial
Official title:
Phase II Trial of Bortezomib and Bendamustine in the Treatment of Relapsed/Refractory Myeloma
Patients with myeloma that has either not responded to previous treatment or has returned
after previous treatment will be given a combination of the drugs bendamustine and
bortezomib.
The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4
of each cycle, with bortezomib being given first, before each dose of bendamustine. Each
cycle will be 28 days long, so patients will be treated the first week of each cycle and then
have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22
of each cycle. Patients will receive the study drugs until their disease progresses or they
are withdrawn from the study.
In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to
show that the combination of bortezomib and bendamustine will have activity in
relapsed/refractory myeloma.
Patients with relapsed and refractory myeloma who have a measurable paraprotein in the serum
or urine or measurable protein by Freelite or measurable disease by plasmacytoma will be
given a combination of bendamustine and bortezomib each cycle. Response rate (PR or better
after 2 cycles) and duration of response will be assessed. Therapy will be continued until
disease progression. The bendamustine would be used in a day 1, day 4 dosing schedule after
each dose of bortezomib to take advantage of the chemosensitizing properties of bortezomib.
This minimizes the days of treatment to just the first week and allows rebound of blood
counts. This will be a phase II trial with dose reduction as necessary.
Bendamustine is a drug which appears to be non-cross-resistant with other alkylating agents
in vitro and in vivo. Thus, we hypothesize that the combination of bortezomib and
bendamustine will have activity in relapsed/refractory myeloma.
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