Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010
- Understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at time of signing the informed consent form.
- Have multiple myeloma and were enrolled in either THAL-MM-003, CC-5013-MM-009, or
CC-5013-MM-010 and discontinued study therapy with thalidomide and high-dose
dexamethasone or high-dose dexamethasone alone due to:
documented disease progression OR inability to tolerate the lowest dosing regimen allowed
on previous protocol without a grade 3 or 4 toxicity.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0,1,2
- Recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (NCI CTC)
- Females of child-bearing potential must agree to using two methods of contraception
- Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior
development of a grade ≥ 3 rash or desquamation while taking thalidomide National
Cancer Institute Common toxicity Criteria (NCI CTC)
- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization
or use of any experimental non-drug therapy within 56 days of initiation of drug
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
will prevent the patient from signing the informed consent form or that will place
the subject at an unacceptable risk for toxicity if he/she participates in the study.
- Pregnant or lactating females.
- Prior therapy with CC-5013.
- Prior history of malignancy, 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 disease for ≥ 3 years