A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia

February 8, 2012 updated by: Cancer Trials Australia

A Single Arm, Phase II Study of the Anti-Blys Monoclonal Antibody, Belimumab in Symptomatic Waldenstroms Macroglobulinaemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3181
      • Melbourne, Victoria, Australia, 3002
        • Recruiting
        • The Peter MacCallum Cancer Centre
        • Principal Investigator:
          • David Ritchie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of Belimumab infusions in symptomatic WM
Time Frame: Patients are assessed every 28 days while on treatment
Patients are assessed every 28 days while on treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of IgM paraprotein
Time Frame: Serum Immunoglobulins will be tested every 28 days
Serum Immunoglobulins will be tested every 28 days
Reduction of splenomegaly and/or lymphadenopathy
Time Frame: This will be tested every 28 days
This will be tested every 28 days
Improvement in anaemia
Time Frame: Patients will be assessed every 28 days while on treatment
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
Pharmacokinetics will be performed on days 1, 15, 56, 168, 364

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Australia

Collaborators

Human Genome Sciences Inc.

Investigators

  • Principal Investigator: David Ritchie, The Peter MacCallum Cancer Centre
  • Principal Investigator: Andrew Spencer, The Alfred

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

January 1, 2013

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (ESTIMATE)

June 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGSI Belimumab in WM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Symptomatic Waldenstroms Macroglobulinaemia

Clinical Trials on Belimumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe