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

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. |
- 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 ]

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

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 Ritchie | +61396561111 | david.ritchie@petermac.org |
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 |
Principal Investigator: | David Ritchie | The Peter MacCallum Cancer Centre | |
Principal Investigator: | Andrew Spencer | The Alfred |
Other Publications:
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 |
Waldenstroms Belimumab anti Blys monoclonal antibody |
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 |