Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.

NCT00812968 | Completed Phase 2 Results DMC

• 1 other identifier: CC-5013-MDS-007
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \[pharmacokinetics\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE)

  An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE): * Death; * Life-threatening event; * Any inpatient hospitalization or prolongation of existing hospitalization; * Persistent or significant disability or incapacity; * Congenital anomaly or birth defect; * Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.

  After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).

Secondary Outcomes (19)

• Maximum Observed Plasma Concentration (Cmax) of Lenalidomide

  Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

• Time to Maximum Plasma Concentration (Tmax) of Lenalidomide

  Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

• Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide

  Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

• Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide

  Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide

  Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).

Also known as: CC-5013

Lenalidomide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must understand and voluntarily sign an informed consent form.
• Age ≥ 20 years at the time of signing the informed consent form.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
• Symptomatic anemia secondary to MDS defined as:Untransfused Hb level \< 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia

You may not qualify if:

• 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.
• Prior therapy with lenalidomide.
• Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) \< 750 cells/μL (0.75 x 10\^9/L) Platelet count \< 50,000/μL (50x10\^9/L) Serum creatinine \> 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3.0 x Upper Limit of Normal (ULN)

Sponsors & Collaborators

• Celgene: lead

Study Sites (6)

Celgene Clinical Site

Shimono, Tochigi, 329-0498, Japan

Location

Celgene Clinical Site

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Celgene Clinical Site

Hiroshima, 734-8551, Japan

Location

Celgene Clinical Site

Kyoto, 601-1495, Japan

Location

Celgene Clinical Site

Osaka, 543-8555, Japan

Location

Celgene Clinical Site

Shizuoka, 420-8527, Japan

Location

Related Publications (2)

• Matsuda A, Taniwaki M, Jinnai I, Harada H, Watanabe M, Suzuki K, Yanagita S, Suzuki T, Yoshida Y, Kimura A, Tsudo M, Tohyama K, Takatoku M, Ozawa K. Morphologic analysis in myelodysplastic syndromes with del(5q) treated with lenalidomide. A Japanese multiinstitutional study. Leuk Res. 2012 May;36(5):575-80. doi: 10.1016/j.leukres.2011.11.011. Epub 2011 Dec 15.

  PMID: 22172461 BACKGROUND

• Harada H, Watanabe M, Suzuki K, Yanagita S, Suzuki T, Yoshida Y, Kimura A, Tsudo M, Matsuda A, Tohyama K, Taniwaki M, Takeshita K, Takatoku M, Ozawa K. Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality. Int J Hematol. 2009 Oct;90(3):353-360. doi: 10.1007/s12185-009-0400-8. Epub 2009 Aug 25.

  PMID: 19705057 RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Masaaki Takatoku, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 22, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 19, 2019
• Results First Posted: December 17, 2013

Record last verified: 2019-11

Locations

JP (6)