Multiple MyelomaPhase 2NCT00315757
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Mapatumumab and Bortezomib in people with Multiple Myeloma, run by Human Genome Sciences Inc. at 20 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Mapatumumab and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 20 sitesin 4 countries
- Study dates
- May 2006to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States8 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Chicago
Chicago, Illinois, 60637
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Scripps Clinic Medical Group, Inc.
La Jolla, California, 92037
Cancer and Blood Disorders Center
Lecanto, Florida, 34461
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Australia4 sites
Institute of Medical & Veterinary Science
Adelaide, South Australia, 5000
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Clinical Haematology & BMT, Alfred Hospital
Melbourne, Victoria, 3181
Department of Haematology, Royal North Shore Hospital
St Leonards, New South Wales, 2065
Canada4 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Notre Dame Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4M1
Ottawa Health Research Institute - General Campus
Ottawa, Ontario, K1Y 4E9
India4 sites
Bangalore Institute of Oncology
Bangalore, 560027
Bharath Hospital & Institute of Oncology
Mysore, Karnataka, 570 017
All India Institute of Medical Sciences
New Delhi, 110 029
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, 110 085
About this study
Official 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
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).
- Conditions
- Multiple Myeloma
- Being tested
- Mapatumumab, Bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapatumumabBiological
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.
MapatumumabBiological
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.
BortezomibDrug
Also called Velcade
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Bortezomib Receives: Drug: Bortezomib |
| B-10 | Experimental | Bortezomib and Mapatumumab 10 mg/kg Receives: Biological: Mapatumumab; Drug: Bortezomib |
| B-20 | Experimental | Bortezomib and Mapatumumab 20 mg/kg Receives: Biological: Mapatumumab; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
Measured: 17 cycles (up to a year)
Secondary outcomes (1)
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
Measured: 17 cycles (up to a year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study chair, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315757
- Sponsor's protocol ID
- HGS1012-C1055
- Status last verified
- Aug 2013
- First submitted
- 17 Apr 2006
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00315757
- Acronym / sponsor ID
- HGS1012-C1055
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: BortezomibBortezomib |
| B-10 | Experimental | Biological: Mapatumumab, Drug: BortezomibBortezomib and Mapatumumab 10 mg/kg |
| B-20 | Experimental | Biological: Mapatumumab, Drug: BortezomibBortezomib and Mapatumumab 20 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mapatumumab10 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. | Biological | B-10 |
| Mapatumumab20 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. | Biological | B-20 |
| BortezomibAlso: Velcade1.3 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. | Drug | A, B-10, B-20 |
Primary outcome
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
Time frame: 17 cycles (up to a year)
1 secondary outcome
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
Time frame: 17 cycles (up to a year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study chair
GlaxoSmithKline
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mapatumumab and Bortezomib in people with Multiple Myeloma, run by Human Genome Sciences Inc. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia, Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone (time frame: 17 cycles (up to a year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.