Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma
remains a non-curable disease however, newer medications and their combinations appear to
provide higher response rates and higher complete response rates than current treatment
options. One of the new medications in multiple myeloma is Velcade. Preliminary results from
a study using a combination of Velcade with Doxil have shown high response rates (disease
reduction). Preliminary results also show that an addition of dexamethasone to Velcade in
patients not responding to Velcade alone showed improved response rates. This study involves
treatment with a new combination of three standard medications: Velcade, Doxil, and
dexamethasone (VDd combination). The proposed combination of all three drugs may improve
efficacy and response.
Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple
myeloma patients who have received at least two prior therapies and have demonstrated disease
progression on the last therapy. Velcade is still currently under investigation for other
indications. Doxil is not approved for use in multiple myeloma but is an approved drug for
use in patients with some other cancers. Several published clinical trials provide evidence
that Doxil is an active agent in multiple myeloma and it is used in treatment combinations
for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple
myeloma, but is not approved by the FDA for that use. The combination of all three drugs is
experimental (not FDA approved).
The goals of this study are to determine if this new combination therapy with Velcade, Doxil
and dexamethasone is an effective treatment and also to determine the side effects that occur
when this combination treatment is given.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center