Status:
UNKNOWN
A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
Lead Sponsor:
Cancer Trials Australia
Collaborating Sponsors:
Human Genome Sciences Inc.
Conditions:
Symptomatic Waldenstroms Macroglobulinaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 producti...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Diagnosis of WM histologically confirmed on bone marrow biopsy.
- Detectable IgM paraprotein \>5 g/L
- Less than 3 lines of prior therapy for WM
- Full blood count within 4 weeks prior to screening shows ANC \>1.0 x109/l AND platelet count \>50 x109/l
- Therapy indicated due to development of one or more of the following:
- symptomatic anaemia
- hyperviscosity symptoms
- rapidly rising paraprotein of \>25% or \>5g/l over 3 months
- splenomegaly
- bulky lymphadenopathy
- B symptoms or paraneoplastic phenomena, which, in the opinion of the investigator are the result of progressive WM.
- Life expectancy \>12 months
- ECOG \< 3
- Able to provide informed consent
- Ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the protocol procedures, including required study visits.
- Subjects of child bearing potential must agree to use effective contraception throughout the study and for 3 months after the last dose of belimumab
Exclusion
- Prior therapy with belimumab.
- Pregnant or breast feeding
- Chemotherapy, immunotherapy or biological therapy within 4 weeks of enrolment. Therapeutic plasma exchange can continue- see section 3.1.4.
- Creatinine clearance (calculated by Cockcroft-Gault) \< 60ml/min
- Bilirubin \>2x ULN, ALT \>2x ULN.
- History of an allergic or anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies, a history of severe allergic reaction to drugs, food, or insects requiring medical intervention, or a history of hypersensitive triad (having all 3 features of allergic rhinitis with nasal polyps, asthma, and aspirin sensitivity).
- Prior opportunistic infection including tuberculosis or atypical mycobacterial infection, multi-dermatome Herpes Zoster or Pneumocystis pneumonia or invasive fungal infection (not including oral or vaginal candidiasis or superficial dermatophytes) .
- Active infection with hepatitis B, hepatitis C or HIV or historically positive test or test positive at screening for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody.
- History of organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- Planned surgical procedure during the treatment period of this study or a history of any other medical disease (eg, cardiopulmonary), laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
- Hospitalization for treatment of infection within 60 days of Day 1.
- Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 1.
- Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01142011
Start Date
November 1 2009
End Date
January 1 2013
Last Update
February 10 2012
Active Locations (2)
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1
The Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
2
Alfred Health
Melbourne, Victoria, Australia, 3181