This trial is active, not recruiting.

Condition multiple myeloma
Treatment cc-5013
Phase phase 3
Sponsor Celgene Corporation
Start date April 2003
End date October 2009
Trial size 700 participants
Trial identifier NCT00622336, 2004-002102-30, CC-5013-MM-012


To evaluate the safety of CC-5013 monotherapy in subjects with advanced multiple myeloma who discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Oral 25mg daily on Days 1-21 every 28 days
cc-5013 Revlimid
Oral 25mg daily on Days 1-21 every 28 days.

Primary Outcomes

Number of Participants with Adverse Events
time frame: Up to 70 months

Secondary Outcomes

Time to progression
time frame: Up to 70 months
Myeloma Response Rate
time frame: Up to 70 months
Duration of Response Rate
time frame: Up to 70 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 treatment - 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Celgene Corporation.