Protocol of the Combination of Bortezomib and Tipifarnib for Relapsed or Refractory Multiple Myeloma
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Emory University
Collaborators:
Millennium Pharmaceuticals, Inc. Ortho Biotech, Inc.