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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
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
Cancer Trials Australia

Study Description
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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 production of monoclonal IgM, resulting in a reduction of IgM paraprotein.

Condition or disease Intervention/treatment Phase
Symptomatic Waldenstroms Macroglobulinaemia Drug: Belimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Belimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Belimumab

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).

 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Belimumab infusions in symptomatic WM [ Time Frame: Patients are assessed every 28 days while on treatment ]

Secondary Outcome Measures :
  1. Reduction of IgM paraprotein [ Time Frame: Serum Immunoglobulins will be tested every 28 days ]
  2. Reduction of splenomegaly and/or lymphadenopathy [ Time Frame: This will be tested every 28 days ]
  3. Improvement in anaemia [ Time Frame: Patients will be assessed every 28 days while on treatment ]
  4. Correlate the degree of response with Belimumab levels [ Time Frame: Pharmacokinetics will be performed on days 1, 15, 56, 168, 364 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. symptomatic anaemia
    2. hyperviscosity symptoms
    3. rapidly rising paraprotein of >25% or >5g/l over 3 months
    4. splenomegaly
    5. bulky lymphadenopathy
    6. 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: David Ritchie Ritchie +61396561111 david.ritchie@petermac.org

Locations
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Australia, Victoria
The Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3002
Principal Investigator: David Ritchie         
Alfred Health Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Andrew Spencer    +61390762000    aspencer@netspace.net.au   
Principal Investigator: Andrew Spencer         
Sponsors and Collaborators
Cancer Trials Australia
Human Genome Sciences Inc.
Investigators
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Principal Investigator: David Ritchie The Peter MacCallum Cancer Centre
Principal Investigator: Andrew Spencer The Alfred
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Cancer Trials Australia
ClinicalTrials.gov Identifier: NCT01142011    
Other Study ID Numbers: HGSI Belimumab in WM
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by Cancer Trials Australia:
Waldenstroms
Belimumab
anti Blys
monoclonal antibody
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs