Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma|
- Estimate an overall response rate to combination therapy with VELCADE, Doxil, and Dexamethasone, defined as at least partial response (PR), i.e. > 50% reduction in serum monoclonal protein and/or >90% reduction in Bence-Jones protein by EBMT criteria. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Multiple myeloma remains a non-curable disease. Combination therapies such as VAD have been effective, with partial response rates in ~40-60% range and tolerable toxicity. The purpose of this study is to see if this combination is more effective
- Estimate a rate of complete response (CR), very good partial response (VGPR, >90% reduction in serum monoclonal protein), minimal response (MR, >25% and <50% reduction in monoclonal) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Estimate the duration of response, progression-free survival, overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
VELCADE will be used biweekly at 1.3 mg/m2 during week 1 and 2 on (days
1, 4, 8, and 11) followed by a 1-week break.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135187
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Andrzej J Jakubowiak, MD, PhD||University of Michigan Cancer Center|