The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Bendamustine Plus Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
Official Title: Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma
Study ID: NCT01168804
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Hanusch Hospital Vienna, Vienna, , Austria
Wilhelminenspital Vienna, Vienna, , Austria
Clinic Wels-Grieskirchen, 4th Internal Dept., Wels, , Austria
Faculty Hospital Brno, Brno, , Czech Republic
Name: Heinz P. Ludwig, Univ. Prof.
Affiliation: Wilhelminenspital Vienna
Role: PRINCIPAL_INVESTIGATOR