A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142011
|Contact: David Ritchie Ritchiefirstname.lastname@example.org|
|The Peter MacCallum Cancer Centre||Recruiting|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator: David Ritchie|
|Melbourne, Victoria, Australia, 3181|
|Contact: Andrew Spencer +61390762000 email@example.com|
|Principal Investigator: Andrew Spencer|
|Principal Investigator:||David Ritchie||The Peter MacCallum Cancer Centre|
|Principal Investigator:||Andrew Spencer||The Alfred|