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
  Purpose

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.


Condition Intervention
Leukemia
Amyloidosis
Drug: Lenalidomide
Drug: Melphalan
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety and tolerability of Intervention

Secondary Outcome Measures:
  • Hematologic and organ responses, time to progression

Enrollment: 25
Study Start Date: April 2009
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890552

Locations
United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
Investigators
Principal Investigator: Stanley L Schrier Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanley L Schrier, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00890552     History of Changes
Other Study ID Numbers: HEM0010, RV-AMYL-PI-0375, SU-09192008-1300
Study First Received: April 28, 2009
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Melphalan
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on September 22, 2014