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Therapeutic Areas: Hematology | Immunology | Genetic Disease
Disease Category: Amyloidosis
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E4A08: A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan, and Dexamethasone (BMDex) for Untreated Patients with Systemic Light-chain (AL) Amyloidosis Ineligible for Autologous Stem-cell Transplantation

Purpose

This research study is being done to compare two possible treatments for immunoglobulin light chain amyloidosis, a disease in which a type of protein collects in multiple organs and tissues in your body, often including the kidney. We will compare the effects, good and/or bad, of the standard two-drug combination treatment, against an experimental three-drug combination.

The two-drug combination is treatment with melphalan and dexamethasone. The three-drug combination includes both of those drugs, plus the drug bortezomib. Bortezomib is considered investigational for immunoglobulin light chain amyloidosis, and is not a standard treatment for this disease. In this study, the patient will get either the two-drug combination or three-drug combination. The patient will not get both.

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • Women must not be pregnant or breast-feeding due to possible damage to unborn child or to an infant. All females of childbearing potential must have a blood test or urine study within 28 days prior to randomization to rule out pregnancy
  • Patients must have measurable disease

Patient Exclusion Criteria:

  • Not eligible or refuses auto-stem cell transplant
  • Women must not be pregnant or breast-feeding due to possible damage to unborn child or to an infant.
  • Patients with clinically overt myeloma (hypercalcemia or lytic bone lesions) are not eligible
  • Patients with non-AL amyloidosis are NOT eligible
  • To Learn more
    Phase

    3

    Gender

    Both Male and Female

    Age

    18 and up

    Overall Status

    Recruiting

    Facility Type

    N/A

    Contact

    Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
    Sherman Health
    1425 North Randall Road
    Elgin, IL 60123
    Phone: 224-783-2907
    Fax: 224-783-3071

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    If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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    CW ID: 183102

    Date Last Changed: July 17, 2013


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