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A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia


Phase 2
20 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Description:

Number of participants with adverse events

Outcome Time Frame:

Approximately 3 years

Safety Issue:

Yes

Principal Investigator

Masaaki Takatoku, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CC-5013-MDS-007

NCT ID:

NCT00812968

Start Date:

September 2007

Completion Date:

September 2010

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Lenalidomide
  • Congenital Abnormalities
  • Myelodysplastic Syndromes
  • Preleukemia

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