- Understand and voluntarily sign an informed consent form.
- Age greater than 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosed with active multiple myeloma and be considered to have disease progression
after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive
disease after treatment.
- Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted
in a 24-hour collection sample).
- Eastern Cooperative Group (ECOG) Performance Status of 0-2. Performance status of 3
and 4 will be allowed if related to bony disease.
- Bilirubin < 2 x upper limits of normal (ULN).
- Liver enzymes (ALT or AST) < 3 x ULN.
- Must have adequate bone marrow function: * Absolute neutrophil count > 1,000
cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥
- Must have adequate renal function: creatinine ≤ 2.5 mg/dL.
- Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose
of study drug.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days of starting study drug. In addition, sexually active WCBP must
agree to use adequate contraceptive methods (oral, injectable, or implantable
hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive
with spermicide; or vasectomized partner) while on study drug. WCBP must agree to
have pregnancy tests every 4 weeks while on study drug.
- Severe infection requiring intravenous antibiotic treatment.
- Life expectancy of less than 3 months.
- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in-situ cervical cancer, or other cancer from which the subject has been
disease-free for at least 5 years.
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
- Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or
doxorubicin plus Doxil®.
- Prior treatment with CC-5013.
- Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while
- Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking
- History of cardiac disease, with New York Heart Association Class II or greater.
- Uncontrolled medical problems such as diabetes mellitus, coronary artery disease,
hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases
unless renal insufficiency is felt to be secondary to multiple myeloma.
- Any investigational agent or systemic anti-myeloma therapy within 28 days of the
first dose of treatment.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.