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Spots Global Cancer Trial Database for Bendamustine Plus Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Heinz P. Ludwig, Univ. Prof.

Affiliation: Wilhelminenspital Vienna

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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