Hypothesis; That inhibition of plasma Blys by the monoclonal antibody Belimumab will reduce both the survival of the lymphoplasmacytoid cells of Waldenstrom Macroglobulinaemia (WM), and their production of monoclonal IgM, resulting in a reduction of IgM paraprotein.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The first cycle of Belimumab (10mg/kg by intravenous (IV) infusion) is a loading cycle of 3 doses over 28 days (days 1, 15, 29). After the first cycle, additional cycles of belimumab (10mg/kg by intravenous (IV) infusion) will be administered every 28 ± 1 days (cycle 2 and all subsequent cycles). The infusion will be administered over a minimum period of 1 hour.
The Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGAlfred Health
Melbourne, Victoria, Australia
RECRUITINGSafety of Belimumab infusions in symptomatic WM
Time frame: Patients are assessed every 28 days while on treatment
Reduction of IgM paraprotein
Time frame: Serum Immunoglobulins will be tested every 28 days
Reduction of splenomegaly and/or lymphadenopathy
Time frame: This will be tested every 28 days
Improvement in anaemia
Time frame: Patients will be assessed every 28 days while on treatment
Correlate the degree of response with Belimumab levels
Time frame: Pharmacokinetics will be performed on days 1, 15, 56, 168, 364
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