A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
Recruitment status was: Recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm, Phase II Study of the Anti-Blys Monoclonal Antibody, Belimumab in Symptomatic Waldenstroms Macroglobulinaemia|
- Safety 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 ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
The first cycle of Belimumab is a loading cycle of 3 doses over 28 days (days 1, 15, 29).
After the first cycle, additional cycles of belimumab will be administered every 28 ± 1 days (cycle 2 and all subsequent cycles).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142011
|The Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3002|
|Melbourne, Victoria, Australia, 3181|
|Principal Investigator:||David Ritchie||The Peter MacCallum Cancer Centre|
|Principal Investigator:||Andrew Spencer||The Alfred|