Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01142011




Registration number
NCT01142011
Ethics application status
Date submitted
10/06/2010
Date registered
11/06/2010
Date last updated
10/02/2012

Titles & IDs
Public title
A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia
Scientific title
A Single Arm, Phase II Study of the Anti-Blys Monoclonal Antibody, Belimumab in Symptomatic Waldenstroms Macroglobulinaemia
Secondary ID [1] 0 0
HGSI Belimumab in WM
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Waldenstroms Macroglobulinaemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belimumab

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).


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Belimumab infusions in symptomatic WM
Timepoint [1] 0 0
Patients are assessed every 28 days while on treatment
Secondary outcome [1] 0 0
Reduction of IgM paraprotein
Timepoint [1] 0 0
Serum Immunoglobulins will be tested every 28 days
Secondary outcome [2] 0 0
Reduction of splenomegaly and/or lymphadenopathy
Timepoint [2] 0 0
This will be tested every 28 days
Secondary outcome [3] 0 0
Improvement in anaemia
Timepoint [3] 0 0
Patients will be assessed every 28 days while on treatment
Secondary outcome [4] 0 0
Correlate the degree of response with Belimumab levels
Timepoint [4] 0 0
Pharmacokinetics will be performed on days 1, 15, 56, 168, 364

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2013
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Cancer Trials Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Human Genome Sciences Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Ritchie
Address 0 0
The Peter MacCallum Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Ritchie Ritchie
Address 0 0
Country 0 0
Phone 0 0
+61396561111
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Moore PA, Belvedere O, Orr A, Pieri K, LaFleur DW,... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01142011