Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03085 CELGENE-CC-5013-MDS-003, NCT00074126

Objectives

Primary

1. Determine the efficacy of CC-5013, in terms of hematological improvement, in patients with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic syndromes and a del(5)(q31q33) cytogenetic abnormality.

Secondary

1. Determine the safety of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a del(5)(q31q33) cytogenetic abnormality
  • Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q- syndrome) OR may be associated with other cytogenetic abnormalities



• Red blood cell (RBC) transfusion-dependent anemia defined as having received at least 2 units of RBCs within the past 8 weeks

Prior/Concurrent Therapy:

Biologic therapy

• No prior CC-5013
• More than 7 days since prior hematopoietic growth factors
• No concurrent epoetin alfa for MDS

Chemotherapy

• More than 28 days since prior experimental or standard chemotherapy for MDS
• No concurrent chemotherapy for MDS

Endocrine therapy

• More than 28 days since prior chronic use (greater than 2 weeks in duration) of more than physiologic doses of corticosteroids
• No concurrent androgens for MDS

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 28 days since prior experimental or standard immunosuppressive or cytoprotective agents for MDS
• More than 28 days since other prior experimental or standard drugs or therapy for MDS
• No other concurrent investigational agents for MDS

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 500/mm³
• Platelet count at least 50,000/mm³
• No clinically significant anemia due to iron, B₁₂, or folate deficiency, autoimmune or hereditary hemolysis, or gastrointestinal bleeding
• If marrow aspirate not evaluable for storage iron, the following criteria must be met:
  • Transferrin saturation at least 20%
  • Serum ferritin at least 50 ng/mL

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST and ALT no greater than 3.0 times upper limit of normal

Renal

• Creatinine no greater than 2.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide
• No prior grade 3 or greater rash or any desquamation (blistering) from thalidomide
• No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study participation or giving informed consent or confound study results
• No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

Expected Enrollment

A total of 36 patients will be accrued for this study.

Outline

This is an open-label, multicenter study.

Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

List AF, Dewald G, Bennett J, et al.: Hematologic and cytogenetic (CTG) response to lenalidomide (CC-5013) in patients with transfusion-dependent (TD) myelodysplastic syndrome (MDS) and chromosome 5q31.1 deletion: results of the multicenter MDS-003 study. [Abstract] J Clin Oncol 23 (Suppl 16): A-5, 2s, 2005.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Stephen Nimer, MD, Principal investigator		Ph: 212-639-7871; 800-525-2225

Registry Information
Official Title		A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects with Myelodysplastic Syndromes Associated with a DEL (5q) Cytogenetic Abnormality
Trial Start Date		2003-07-22
Trial Completion Date		2009-05-12
Registered in ClinicalTrials.gov		NCT00074126
Date Submitted to PDQ		2003-10-22
Information Last Verified		2009-08-05
NCI Grant/Contract Number		CA08748

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