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Myelodysplastic/Myeloproliferative Syndromes

Lenalidomide With or Without Epoetin Alfa for Myelodysplastic Syndrome
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®) Alone and in Combination With Epoetin Alfa (Procrit®) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Status Conditions Phase Study ID
Recruiting Myelodysplastic Syndromes Phase III NCT00843882
Summary

RATIONALE: Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

PURPOSE: This randomized phase III trial is studying lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.



Investigator
Fred Appelbaum, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

DISEASE CHARACTERISTICS:

  • Documented diagnosis of 1 of the following:

    • Myelodysplastic syndromes (MDS) lasting ≥ 3 months according to WHO criteria

      • Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
    • Non-proliferative chronic myelomonocytic leukemia (WBC < 12,000/mm³)
  • International prognostic scoring system (IPSS) category of low- or intermediate-1-risk MDS as determined by cytogenetic analysis

    • Cytogenetic analysis required if current bone marrow biopsy is a dry tap
    • Patients with cytogenetic failure and < 10% marrow blasts are eligible

      • Patients with cytogenetic failure must have prior cytogenetic results (FISH is not a substitute) within 6 months after completion of the last type of MDS treatment (in this case, growth factors are not considered a type of MDS treatment).
  • Must have symptomatic anemia with hemoglobin < 9.5 g/dL* (transfusion independent or RBC transfusion-dependent [i.e., ≥ 2 units/month]) within the past 8 weeks NOTE: *For transfusion independent patients, ≥ 2 pre-transfusion or un-transfused hemoglobin values are required
  • Must have failed treatment with an erythropoietic growth factor OR have a low probability of response to rhu-erythropoietin, as defined by the following:

    • Prior erythropoietin failure: requires ≥ 40,000 units epoetin alfa/week for 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks and failed to achieve transfusion independence (in transfusion dependent patients) or failed to achieve ≥ 2 g rise in hemoglobin sustained for ≥ 4 weeks (in transfusion independent patients)
    • Low erythropoietin response profile: rhu-erythropoietin and epoetin alfa-naive patients receiving ≥ 2 U pRBC/month for ≥ 8 weeks and serum erythropoietin ≥ 500 mU/mL in the 8 weeks prior to study randomization for a hemoglobin < 9.5 g/dL

PATIENT CHARACTERISTICS:

  • ANC ≥ 500/mm^3 (myeloid growth factor support independent)
  • Platelet count ≥ 50,000/mm^3 (platelet transfusion independent)
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 30 mL/min
  • AST and ALT ≤ 2.0 times ULN
  • Serum total bilirubin < 3.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception for ≥ 4 weeks before, during, and for 4 weeks after completion of study treatment
  • No uncontrolled seizures or uncontrolled hypertension
  • No history of other malignancy (except basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix or breast) unless the patient has been confirmed disease-free for ≥ 3 years
  • No serious medical condition or any other unstable medical comorbidity, or psychiatric illness that would preclude informed consent or put the patient at unacceptable risk during study treatment
  • No thromboembolic events within the past 3 years
  • No known allergic reaction to epoetin alfa (Procrit®) or human serum albumin
  • No prior desquamating (blistering) rash from thalidomide
  • No prior allergic reactions to thalidomide ≥ grade 3
  • No known HIV-1 seropositivity
  • No documented iron deficiency

    • Must have documented bone marrow iron stores (if marrow iron stain is not available, transferrin saturation must be > 20% or serum ferritin > 100 ng/mL)
  • No clinically significant anemia resulting from iron, B_12, or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior lenalidomide
  • Prior thalidomide allowed
  • More than 8 weeks since prior cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS
  • At least 28 days since prior non-transfusion therapy, including all types of growth factors, for MDS

    • Concurrent prophylactic hydrocortisone to prevent transfusion reaction allowed
  • Concurrent steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic allowed

Last Updated
June 05, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.