A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease
- Determine the complete hematologic response rate at 12 months.
- Determine the overall hematologic response rate.
- Determine the organ response rate.
- Determine time to treatment failure.
- Assess toxicity of the regimen, in terms of incidence and severity of
treatment-emergent peripheral neuropathy and quality of life.
- Determine the overall survival.
OUTLINE: This is a multicenter study.
Patients receive oral melphalan on days 1-4, bortezomib IV on days 1, 8, 15, and 22, and
dexamethasone orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every
4-6 weeks for up to 20 courses in the absence of disease progression or unacceptable
Blood, urine, and bone marrow aspirates are collected at baseline and periodically after
treatment to permit the correlation of clinical results with measured molecular events. A
single baseline peripheral blood DNA sample is collected for future association studies
linking disease onset, progression, and response to administered therapy with single
nucleotide polymorphisms. Blood plasma and urine samples are evaluated for proteomic markers
associated with disease progression and therapeutic response. Peripheral blood RNA samples
are evaluated for transcriptional response to treatment of peripheral blood lymphocytes.
Bone marrow aspirates are collected to extract plasma cells by flow cytometry for gene
Quality of life is assessed at the beginning of each course.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete hematologic response
Up to 12 months
Jeffrey A. Zonder, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|
|Providence Cancer Institute at Providence Hospital - Southfield Campus||Southfield, Michigan 48075|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Sinai-Grace Hospital||Detroit, Michigan 48235|
|Rocky Mountain Cancer Centers/Rocky Mountain Blood & Marrow Transplant Program||Denver, Colorado 80218|