Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma, Myeloma, M-Protein
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Anthracyclines, Liposomes, Liposomal, Vincristine, Doxorubicin, Dexamethasone, Pegylated Liposomal Doxorubicin, DOXIL, drug resistant myeloma
Eligibility Criteria
Inclusion Criteria: Untreated multiple myeloma requiring treatment Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2 Must have measurable disease Left Ventricular Ejection Fraction (LVEF) >= 50 % determined by Multiple Gated Acquisition Scan (MUGA) Karnofsky performance status of >= 60% Adequate bone marrow, liver and renal function Disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Exclusion Criteria: Life expectancy of >= 3 months Pregnant or breast feeding History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months Uncontrolled diabetes mellitus or systemic infection Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent Prior chemotherapy to treat Multiple Myeloma Prior radiotherapy to an area greater than 1/3 of the skeleton Prior local radiotherapy within 1 week of treatment Any investigational agent within 30 days of the first dose of treatment Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.