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A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia

Phase 2
18 Years
Open (Enrolling)
Chronic Myeloproliferative Disorders

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Trial Information

A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia



- Determine the rate of complete or partial remission in patients with myelofibrosis with
myeloid metaplasia treated with lenalidomide and prednisone.


- Determine the toxic effects of this regimen in these patients.

- Determine the duration of response in patients treated with this regimen.

- Determine the effect of this regimen on bone marrow fibrosis, angiogenesis, and
cytogenetics in these patients.

OUTLINE: This is a multicenter study.

For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once
daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28
and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27.
Patients with stable or responding disease after course 3 receive oral lenalidomide alone
once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 5 years from study entry.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 11 months.

Inclusion Criteria


- Diagnosis of myelofibrosis with myeloid metaplasia, including any of the following

- Agnogenic myeloid metaplasia

- Post-polycythemic myeloid metaplasia

- Post-thrombocythemic myeloid metaplasia



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≤ 10 g/dL OR

- Transfusion dependent


- Total or direct bilirubin ≤ 2.0 mg/dL

- AST ≤ 3 times upper limit of normal (unless due to hepatic extramedullary

- No hepatitis A, B, or C infection


- Creatinine ≤ 2.0 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No condition or laboratory abnormality that would preclude study participation

- No other active malignancy

- No known hypersensitivity to thalidomide or lenalidomide


Biologic therapy

- No prior lenalidomide

- At least 28 days since prior interferon alfa, thalidomide, or growth factors

- No concurrent growth factors


- At least 28 days since prior chemotherapy

- At least 28 days since prior hydroxyurea

Endocrine therapy

- At least 28 days since prior systemic corticosteroids


- Not specified


- Not specified


- Recovered from prior therapy

- At least 28 days since prior anagrelide or other myelosuppressive agents

- At least 28 days since prior experimental therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response monthly

Safety Issue:


Principal Investigator

Ayalew Tefferi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • chronic idiopathic myelofibrosis
  • polycythemia vera
  • essential thrombocythemia
  • Primary Myelofibrosis
  • Myeloproliferative Disorders



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