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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - Mapatumumab
Other interventions - 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


Other interventions: 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.

Other interventions: 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
Other interventions
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
The purpose of this study is to evaluate the efficacy (disease response) and safety of
mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or
refractory multiple myeloma (MM).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00315757
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00315757