Clinical trial NCT00065351 (phase 2, 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 or equal to 18 years at the time of signing the informed consent
             form.

          -  Must have a diagnosis of multiple myeloma and have relapsed and refractory disease.
             Such subjects have relapsed after having had at least a partial myeloma paraprotein
             response (greater or equal to 50% reduction of myeloma paraprotein) to prior therapy
             and then continued to develop disease progression despite salvage anti-myeloma
             therapy. Subjects must have documented evidence of disease progression during therapy
             with the last prior anti-myeloma treatment regimen (must have received at least 2
             cycles) prior to study enrollment.Subjects may have been previously treated with
             thalidomide and/or radiation therapy.

          -  Measurable levels of myeloma paraprotein in serum (greater or equal to 0.5 g/dL) or
             urine (greater or equal to 0.2 g excreted in a 24-hour collection sample).

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see
             Appendix II).

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
             test within 7 days of starting study drug.

        Exclusion Criteria:

          -  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 (every 14
             days for women with irregular cycles) and 4 weeks after the last dose of study drug.

          -  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 of the following laboratory abnormalities:

        A) Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) B) Platelet count
        <75,000/mm^3 (75 x 10^9/L) C) Serum creatinine >2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or
        SGPT/ALT >3.0 x upper limit of normal (ULN) E) Serum total bilirubin >2.0 mg/dL (34 umol/L)

          -  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.

          -  Prior history of malignancies other than multiple myeloma (except for basal cell or
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
             unless the subject has been free of the disease for greater than or equal to 3 years.

          -  Prior greater than or equal to grade 3 allergic reaction/hypersensitivity to
             thalidomide.

          -  Prior greater than or equal to grade 3 rash or any desquamating (blistering) rash
             while taking thalidomide.

          -  Prior use of CC-5013.

          -  Use of any standard/experimental anti-myeloma drug therapy within 28 days of the
             initiation of study drug therapy or use of any experimental non-drug therapy within 56
             days of the initiation of study drug therapy