Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma

Exclusion Criteria

• •Patient has a platelet count of \< 50, 000 cells/mm³, within 14 days before enrollment.
• •Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment.
• •Patient has a calculated or measured creatinine clearance of \< 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.
• •Patient has hemoglobin \< 7.5 g/dl.
• •Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
• •Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.
• •Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2.
• •Patient has hypersensitivity to boron or mannitol.
• •Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL.
• •Patient has clinically significant coexisting illness unrelated to myeloma.
• •Patient has uncontrolled diabetes.
• •Patient has plasma cell leukemia.
• •Patient has serum bilirubin \> 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) \> 2.5 x upper normal limit (ULN), or alkaline phosphatase \> 2.5 x ULN.
• •Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• •Patient has received other investigational drugs within 14 days before enrollment.
• •Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.