Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Patients are being asked to take part in this research study because they have multiple
myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial
therapy.
For patients who have relapsed or are refractory to therapy, there is no agreed upon standard
treatment. Treatment options include chemotherapy and, for some patients, bone marrow
transplants. None of the available treatments are curative and investigators are continually
looking for more effective treatments. This study involves treatment with a new combination
of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using
a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other
studies showed that an addition of Dexamethasone to VELCADE in patients not responding to
VELCADE alone improved response rate. The proposed combination of all three drugs may improve
efficacy and response.
VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma.
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 approved for use in multiple myeloma. 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:
N/A
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center