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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00315757




Registration number
NCT00315757
Ethics application status
Date submitted
17/04/2006
Date registered
19/04/2006
Date last updated
8/08/2013

Titles & IDs
Public title
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 2, Multi-Center, Open-Label, Randomized Study of Mapatumumab (TRM-1 [HGS1012], a Fully Human Monoclonal Antibody to TRAIL-R1) in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
HGS1012-C1055
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

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

Active comparator: A - Bortezomib

Experimental: B-10 - Bortezomib and Mapatumumab 10 mg/kg

Experimental: B-20 - Bortezomib and Mapatumumab 20 mg/kg


Treatment: Other: Mapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.

Treatment: Other: Mapatumumab
20 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.

Treatment: Drugs: Bortezomib
1.3 mg/m\^2 IV (in the vein), twice weekly for two weeks (Days 1, 4, 8, and 11) of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
Timepoint [1] 0 0
17 cycles (up to a year)
Secondary outcome [1] 0 0
To evaluate the safety, including the frequency and severity of adverse events and laboratory abnormalities, of mapatumumab in combination with bortezomib and bortezomib alone throughout the study period
Timepoint [1] 0 0
17 cycles (up to a year)

Eligibility
Key inclusion criteria
* Diagnosed with multiple myeloma that is refractory or has relapsed after treatment
* Measurable serum and/or urine M-protein
* Failed 1 or 2 prior therapies for multiple myeloma
* 18 years of age or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received more than 2 prior therapies for multiple myeloma.
* Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
* Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
* Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
* Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
* Subjects who received a stem cell transplant using cells from another individual
* Previously treated with bortezomib or mapatumumab
* Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection
* Infection requiring antibiotics or hospitalization within the last 2 weeks
* Major surgery within the last 4 weeks
* Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
* History of other cancers within the past 5 years
* Pregnant or breast-feeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Department of Haematology, Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Institute of Medical & Veterinary Science - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [4] 0 0
Clinical Haematology & BMT, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
India
State/province [12] 0 0
Karnataka
Country [13] 0 0
India
State/province [13] 0 0
Bangalore
Country [14] 0 0
India
State/province [14] 0 0
New Delhi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Human Genome Sciences Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00315757