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Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients

NCT00536575 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-02-27

Study results available
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Summary

This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. The initial patients on the dose-finding portion of this study will be enrolled through a single institution. Following establishment of the Phase II dose the study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium.

The purpose of this study is to develop the combination of bortezomib (which is proven to be clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of angiogenesis). This regimen will be developed in a schedule that is convenient for patients, and that is as minimally toxic to patients as possible.

Conditions

Interventions

DRUG

Bortezomib

Dose Level 1: Bortezomib 1.3mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle. Dose Level 2: Bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle. Dose Level 3: Bortezomib 1.6mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.

DRUG

Sorafenib

Dose Levels 1 and 2: 200 mg by mouth twice daily Dose Level 3: 400 mg by mouth twice daily

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Ian W. Flinn, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-02-28
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00536575 on ClinicalTrials.gov