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A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia

NCT01142011 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Symptomatic Waldenstroms Macroglobulinaemia

Interventions

DRUG

Belimumab

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.

Sponsors & Collaborators

  • Human Genome Sciences Inc.

    collaborator INDUSTRY

  • Cancer Trials Australia

    lead OTHER

Principal Investigators

  • David Ritchie · The Peter MacCallum Cancer Centre

  • Andrew Spencer · The Alfred

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-06-30
Completion
2013-01-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142011 on ClinicalTrials.gov