An Open-Label Phase I/II Study of Bendamustine, Weekly Bortezomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of
plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the
second most common hematologic malignancy. For many years, alkylating agents have been the
backbone of treatment. The combination of melphalan and prednisone was, for many years, the
standard of care for patients who were not candidates for autologous transplantation.
Melphalan continues to be the primary conditioning agent for autologous transplant,and
cyclophosphamide has also gained a foothold in the treatment of this disease.
The introduction of novel agents has fundamentally changed the landscape of treating this
disease, although the true effects on survival are not yet known. Immunomodulatory agents
and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib, have been
used in both newly diagnosed and relapsed patients. Currently, there is intense clinical
research on the optimal way to combine these novel agents with the traditional backbones of
treatment - including alkylators, with one another and, eventually, with the subsequent
iterations of these classes of drugs. However, despite the therapeutic excitement
surrounding this disease, nearly all patients will relapse, and cure remains an elusive goal
for all but a rare handful.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally Tolerated Dose of Bendamustine
Primary objective of this phase is to determine the MTD of bendamustine when combined with bortezomib, lenalidomide and dexamethasone in subjects with relapsed and/or refractory multiple myeloma.
Laura Michaelis, MD
Loyola Univ Med Cntr - Cardinal Bernardin Cancer Cntr
United States: Food and Drug Administration
|Loyola Univ Med Cntr - Cardinal Bernardin Cancer Center||Maywood, Illinois 60153|