A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
NCT ID: NCT01142011
Last Updated: 2012-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2009-11-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Cancer Trials Australia
OTHER
Responsible Party
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Principal Investigators
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David Ritchie
Role: PRINCIPAL_INVESTIGATOR
The Peter MacCallum Cancer Centre
Andrew Spencer
Role: PRINCIPAL_INVESTIGATOR
The Alfred
Locations
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The Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Rennert P, Schneider P, Cachero TG, Thompson J, Trabach L, Hertig S, Holler N, Qian F, Mullen C, Strauch K, Browning JL, Ambrose C, Tschopp J. A soluble form of B cell maturation antigen, a receptor for the tumor necrosis factor family member APRIL, inhibits tumor cell growth. J Exp Med. 2000 Dec 4;192(11):1677-84. doi: 10.1084/jem.192.11.1677.
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Scapini P, Nardelli B, Nadali G, Calzetti F, Pizzolo G, Montecucco C, Cassatella MA. G-CSF-stimulated neutrophils are a prominent source of functional BLyS. J Exp Med. 2003 Feb 3;197(3):297-302. doi: 10.1084/jem.20021343.
Schiemann B, Gommerman JL, Vora K, Cachero TG, Shulga-Morskaya S, Dobles M, Frew E, Scott ML. An essential role for BAFF in the normal development of B cells through a BCMA-independent pathway. Science. 2001 Sep 14;293(5537):2111-4. doi: 10.1126/science.1061964. Epub 2001 Aug 16.
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Moore PA, Belvedere O, Orr A, Pieri K, LaFleur DW, Feng P, Soppet D, Charters M, Gentz R, Parmelee D, Li Y, Galperina O, Giri J, Roschke V, Nardelli B, Carrell J, Sosnovtseva S, Greenfield W, Ruben SM, Olsen HS, Fikes J, Hilbert DM. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science. 1999 Jul 9;285(5425):260-3. doi: 10.1126/science.285.5425.260.
Other Identifiers
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HGSI Belimumab in WM
Identifier Type: -
Identifier Source: org_study_id
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