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Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma

NCT01177683 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-06

Study results available
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Summary

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

Conditions

Interventions

DRUG

Bendamustine

Phase I component: Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4

DRUG

Doxorubicin

Phase I and II components: Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4

DRUG

Bortezomib

Phase I and II components: Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11

DRUG

Bendamustine

Phase II component: Bendamustine at at MTD IV over 1 hour, Days 1 and 4

DRUG

Filgrastim

Phase II component: Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Cephalon, Inc.

    collaborator INDUSTRY

  • Sherif Farag, MB, BS

    lead OTHER

Principal Investigators

  • Sherif Farag, M.B., B.S. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01177683 on ClinicalTrials.gov