Clinical trial NCT00091624 (phase 1, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: cc-5013
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  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 ≥ 8 g/dL

          -  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.

        Exclusion Criteria:

          -  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
             cell dyscrasia.

          -  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
             taking thalidomide.

          -  Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking
             thalidomide.

          -  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.