A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
Recruitment status was Recruiting
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 Design:||Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
- Reduction of IgM paraprotein [ Time Frame: Serum Immunoglobulins will be tested every 28 days ] [ Designated as safety issue: No ]
- Reduction of splenomegaly and/or lymphadenopathy [ Time Frame: This will be tested every 28 days ] [ Designated as safety issue: No ]
- Improvement in anaemia [ Time Frame: Patients will be assessed every 28 days while on treatment ] [ Designated as safety issue: No ]
- Correlate the degree of response with Belimumab levels [ Time Frame: Pharmacokinetics will be performed on days 1, 15, 56, 168, 364 ] [ Designated as safety issue: No ]
|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
|Contact: David Ritchie Ritchieemail@example.com|
|Melbourne, Victoria, Australia, 3181|
|Contact: Andrew Spencer +61390762000 firstname.lastname@example.org|
|Principal Investigator: Andrew Spencer|
|The Peter MacCallum Cancer Centre||Recruiting|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator: David Ritchie|
|Principal Investigator:||David Ritchie||The Peter MacCallum Cancer Centre|
|Principal Investigator:||Andrew Spencer||The Alfred|