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Therapeutic Areas: Hematology | Immunology | Genetic Disease
Disease Category: Amyloidosis
Location: United States, IL
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
Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
1425 North Randall Road
Elgin, IL 60123
Research Center Information: Sherman Health
If you would like to learn more about participating in this study, please send an email message using the form below.
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