A Phase II Study of Carfilzomib in Relapsed Waldenström's Macroglobulinemia (WM) IST-CAR-531
Waldenström's macroglobulinemia (WM) is a rare low-grade B-cell lymphoplasmacytic lymphoma.
Overall reported incidences approximately 3 cases per million persons per year with about
1500 and cases diagnosed annually in United States. There is a higher incidence in males
compared to females (3.4 vs 1.7 cases per 1 million person-years at risk) and WM is nearly
twice as common among whites compared to blacks.[1] A familial form of the disease is also
recognized. WM is an indolent disease with an overall median survival of 5 years although
more recent data suggest a disease-specific median survival of 11.2 years, given the
frequently older age (median 63 years) and accompanying co-morbidities at diagnosis(1). WM
is characterized by infiltration of lymphoplasmacytic cells and bone marrow and by serum
immunoglobulin M (IgM) monoclonal gammopathy. B-cell origin and some clinical cellular and
epidemiological features are shared among WM arises from intermediately mature B cells
(somatically mutated post germinal center the lymphocytes that have not yet undergone
isotype switching), as opposed to immature B cells from which chronic lymphocytic leukemia
arises in the fully mature, somatically mutated, from which cells multiple myeloma arises.
There is no standard of care for WM (2). Therefore, involving the patient's in clinical
trials is strongly recommended whenever possible.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine overall response rate (ORR) of carfilzomib in bortezomib naïve and bortezomib-exposed relapsed WM
Participants will be evaluated every 28 days (1 cycle) until progression or a maximum of 12 cycles
No
David H Vesole, MD, PhD
Principal Investigator
John Theurer Cancer Center at Hackensack University Medical Center
United States: Food and Drug Administration
Pro 3596 (CAR-531)
NCT01813227
April 2013
April 2016
Name | Location |
---|---|
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |