Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Sites / Locations
- University of Michigan