A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
- Patient is at least 18 years of age.
- Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with
measurable disease by serum or urine. Measurable disease defined as monoclonal
protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M
protein/ 24 hours
- Patient has received at least 1 prior treatment regimen. (Prior treatment with
bortezomib is allowed.)
- Patient has ECOG ≤ 2
- Patient provides voluntary written informed consent before performance of any
study-relates procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
- Patients who have received prior high dose chemotherapy with stem cell support are
eligible for this study.
- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of
- Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before
- Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before
- 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.