Skip Navigation



Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Hematology | Immunology | Genetic Disease
Disease Category: Amyloidosis
Location: United States, IL

Clinical Trial Details


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


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



    Both Male and Female


    18 and up

    Overall Status


    Facility Type



    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

    View Map

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

    Zip/Postal Code:
    Please leave this field empty.

    CW ID: 183102

    Date Last Changed: July 17, 2013

    DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.