drugset / Trial / NCT01315873

Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

NCT01315873 ↗

Phase 2 Terminated 24 enrolled NYU Langone Health Cephalon · collab
NaSingle-groupOpen-labelTreatment

Summary

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 Patients will receive the study drugs until their disease progresses or they are withdrawn from the study.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.

Timeline

Start
2011-09
Primary completion
2014-02
Completion
2015-09

Outcome

Outcome not reported

Stopped: “PI left the institution before all data analysis was completed”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 60 mg/m2 —
Subject Bendamustine Small molecule 75 mg/m2 —
Subject Bendamustine Small molecule 90 mg/m2 —
Subject Bortezomib Small molecule 1.3 mg/m2 —

Indications