A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
|ClinicalTrials.gov Identifier: NCT01142011|
Recruitment Status : Unknown
Verified February 2012 by Cancer Trials Australia.
Recruitment status was: Recruiting
First Posted : June 11, 2010
Last Update Posted : February 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Waldenstroms Macroglobulinaemia||Drug: Belimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Phase II Study of the Anti-Blys Monoclonal Antibody, Belimumab in Symptomatic Waldenstroms Macroglobulinaemia|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||January 2013|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142011
|Contact: David Ritchie Ritchieemail@example.com|
|The Peter MacCallum Cancer Centre||Recruiting|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator: David Ritchie|
|Melbourne, Victoria, Australia, 3181|
|Contact: Andrew Spencer +61390762000 firstname.lastname@example.org|
|Principal Investigator: Andrew Spencer|
|Principal Investigator:||David Ritchie||The Peter MacCallum Cancer Centre|
|Principal Investigator:||Andrew Spencer||The Alfred|