CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Bendamustine +2 moredrug
Likely dose
Bendamustine 80 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01056276
NCT01056276Phase 2Completed

Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

SCRI Development Innovations, LLC·interventional·Posted Jan 26, 2010·Updated May 3, 2017

In Brief

A Phase 2 clinical trial evaluating Bendamustine, Bortezomib, and 1 other intervention for Multiple Myeloma. Completed, enrolled 59 participants across 13 sites.

Detailed Summary

In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2010
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2015
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.4 years ago

Interventions

Bendamustinedrug

Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.

Bortezomibdrug

1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response. Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15

Dexamethasonedrug

20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15