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A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier:
NCT00890552
First received: April 28, 2009
Last updated: February 5, 2014
Last verified: February 2014

April 28, 2009
February 5, 2014
April 2009
May 2013   (final data collection date for primary outcome measure)
Safety and tolerability of Intervention
Same as current
Complete list of historical versions of study NCT00890552 on ClinicalTrials.gov Archive Site
Hematologic and organ responses, time to progression
Same as current
Not Provided
Not Provided
 
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

This open-label trial will evaluate a dose of oral lenalidomide 10 mg taken daily on days 1-21 of 28 day cycle. Oral melphalan 0.18mg/kg will be taken on days 1-4 of a 28 day cycle. Oral dexamethasone 40 mg will be taken on days 1, 8, 15 and 22 of a 28 day cycle. Up to 15 patients over the age of 18 with newly diagnosed or relapsed AL amyloidosis will be included in this study. In the absence of disease progression or toxicity, patients will complete nine cycles of therapy. After nine cycles, subjects have the option of continuing lenalidomide therapy alone. The primary objective of this study is safety and tolerability of the above regimen. The secondary objectives are hematologic and organ responses, as well as time to progression.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Amyloidosis
  • Drug: Lenalidomide
  • Drug: Melphalan
  • Drug: Dexamethasone
Not Provided
Dinner S, Witteles W, Afghahi A, Witteles R, Arai S, Lafayette R, Schrier SL, Liedtke M. Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement. Haematologica. 2013 Oct;98(10):1593-9. doi: 10.3324/haematol.2013.084574. Epub 2013 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >=18 years at the time of signing the informed consent form.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Newly diagnosed or relapsed AL amyloidosis.
  5. Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia (abnormal clonal dominance of plasma cells in the bone marrow, and/or detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine, and/or an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy).
  6. Measurable disease, defined by an abnormal serum free light chain or monoclonal protein by immunofixation, proteinuria >= 0.5g/day, cardiac involvement with interventricular septal thickness >= 15mm, or hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase.
  7. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
  8. ECOG performance status of <= 3 at study entry (see Appendix II).
  9. Laboratory test results within these ranges:

    • Absolute neutrophil count >= 1.0 x 10^9/L.
    • Platelet count >= 75 x 10^9/L
    • Creatinine clearance >= 15mL/minute (calculated by MDRD Equation or Cockcroft-Gault, or measured by 24-hour urine collection).
    • Total bilirubin <= 2-fold upper limits of normal.
  10. Disease free of prior malignancies (excluding multiple myeloma) for >= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  11. All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.
  12. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  13. Able to take aspirin (81 mg) daily or alternative (see below) as prophylactic anticoagulation. Patients intolerant to aspirin may use coumadin or low molecular weight heparin. Patients requiring full dose anticoagulation for a prior thrombosis can take low molecular weight heparin (preferred) or coumadin instead of aspirin.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. Use of any other experimental drug or therapy within 28 days of baseline.
  4. Known hypersensitivity to thalidomide.
  5. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  6. Any prior use of lenalidomide.
  7. Concurrent use of other anti-cancer agents or treatments.
  8. Known positive for HIV.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890552
HEM0010, RV-AMYL-PI-0375, SU-09192008-1300
Yes
Stanley L Schrier, Stanford University
Stanford University
Celgene Corporation
Principal Investigator: Stanley L Schrier Stanford University
Stanford University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP