Status:
COMPLETED
Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Multiple myeloma remains a non-curable disease. Initial therapy with one of the commonly used regimens, such as thalidomide with dexamethasone, VAD, dexamethasone pulses, and melphalan with prednisone...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Histologic confirmation of multiple myeloma
- Patients must have active multiple myeloma requiring first line treatment
- At least 18 years of age
- Female patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 3 months after completing treatment.
- Male patient agrees to use an acceptable method of contraception for the duration of the study and for 3 months after completing treatment.
- Expected survival of at least 6 months
- Patients with abnormal kidney function, including patients on dialysis, are eligible if kidney insufficiency is secondary to multiple myeloma.
- Patients must have adequate liver functions
- Patients may have received up to 2 weeks of high dose steroids. Prior steroid treatment for more than 2 weeks is allowed provided the treatment was given for neurological compromise.
- Prior radiation therapy will be allowed but radiation therapy must be completed prior to registration.
Exclusion
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patient had a myocardial infarction within 6 months of enrollment, history of cardiac disease, or clinical evidence of congestive heart failure.
- Patient previously received 250 mg/m2 or more of doxorubicin (or equivalent for other anthracyclines).
- Patient is known to be human immunodeficiency virus (HIV)-positive (patients assessed to be at risk should be tested).
- Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection (patients assessed by the investigator to be at risk should be tested)
- Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to bortezomib, boron or mannitol, conventional doxorubicin HCL or the components of Doxil, or other study drugs.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient is currently receiving other investigational drug(s).
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00116961
Start Date
June 1 2005
End Date
December 1 2007
Last Update
February 7 2012
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109