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Protocol of the Combination of Bortezomib and Tipifarnib for Relapsed or Refractory Multiple Myeloma

NCT00972712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-03-10

No results posted yet for this study

Summary

The purpose of this study is to test the effect of the combination of bortezomib and tipifarnib. Bortezomib (VELCADE) is approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma patients who have received at least one prior therapy. Tipifarnib is not yet approved by the FDA and is an investigational drug. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. Because these drugs have not been used together before, it is not clear which dose of each agent is optimal when used in combination.

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drugs to use for further studies. The investigators will test the safety of BORTEZOMIB and TIPIFARNIB together and see what effects (good and bad) it has on you and your MULTIPLE MYELOMA, and to find the highest dose of both agents that can be given without causing severe side effects.

Conditions

Interventions

DRUG

Bortezomib and Tipifarnib

Dose level -1: Bortezomib (0.7 mg/m²; days 1,4,8,11); Tipifarnib (100 mg po BID) Dose level 1: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (100 mg po BID) Dose level 2: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (200 mg po BID) Dose level 3: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (300 mg po BID) Dose level 4: Bortezomib (1.0 mg/m²; days 1,4,8,11); Tipifarnib (400 mg po BID) Schema B Dose level 1: Bortezomib (1.3 mg/m²; Days 1,4,8,11); Tipifarnib (300 mg po BID) Dose level 2: Bortezomib (1.3 mg/m²; Days 1,4,8,11); Tipifarnib (400 mg po BID)

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Sagar Lonial, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-12-31
Completion
2015-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00972712 on ClinicalTrials.gov