Monoclonal Gammopathy of Undetermined SignificancePhase 1NCT01219010
A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
A Phase 1 study testing Siltuximab in people with Monoclonal Gammopathy of Undetermined Significance and Multiple Myeloma, run by Janssen Research & Development, LLC at 8 sites in 3 countries.
Trial summary
The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Plasma Cell Neoplasm
- What is being tested?
- Siltuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Oct 2010to Mar 2014
- Phase
- Phase 1
- 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
- Diagnosis of MGUS (measurable serum M-protein < 3 g/dL AND clonal bone marrow plasma cells < 10% without any end organ damage), SMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% without any end organ damage) or IMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% and = 3 lytic bone lesions but no other end organ damage)
- Qualifying ECG results that will be checked by a central laboratory
- Negative urine drug screen for substances of abuse
- Qualifying hematology and chemistry laboratory results.
Who cannot join
- Diagnosis of symptomatic multiple myeloma
- Prior exposure to approved or investigational myeloma treatments
- Prior exposure to agents targeting IL-6 or the IL-6 receptor
- Significant cardiac disease
- Skin condition likely to interfere with ECG electrode placement, breast implant, or thoracic surgery
- Received medications known to affect the QT interval
- Vaccination with live, attenuated vaccines within 4 weeks
- Major surgery or radiation within 4 weeks
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States3 sites
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Houston, Texas
About this study
Official title: A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.
Read the detailed description
This is a research study with an experimental drug called siltuximab (also known as CNTO 328). Currently there are studies with siltuximab, completed or ongoing, in patients with blood cancers such as multiple myeloma and Castleman's disease and with solid tumors such as kidney, ovarian and prostate cancer, to see if siltuximab is safe and to determine what effects it has on these types of cancer. This study is being done in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM) to determine if siltuximab has an effect on heart function measured by ECG recordings, and more specifically to determine if siltuximab has any effect on the QT interval. MGUS, SMM and IMM patients usually go on to develop active multiple myeloma which is a type of cancer that affects the blood and bone marrow. The cancer cells in the bone marrow can cause the normal bone marrow cells to breakdown. This can result in low levels of red blood cells (which may make the patient feel tired or fatigued), low levels of white blood cells (which may increase the patient's chances of infections) or low levels of platelets (which may increase risk of bleeding). The cancer cells can cause damage to the normal bone. This can cause bone pain, bone fractures, and can increase the level of calcium in the blood. The cancer cells also make proteins (called M-proteins), which can result in damage to other organs, especially the kidneys. Siltuximab is a chimeric (part mouse and part human) antibody (immunoglobulin that is important for fighting infection). It does this by blocking another small protein called Interleukin 6 (IL-6). The body makes IL-6 naturally, and at normal levels it is important for the inflammatory response. But high levels of IL-6 can help cancer cells grow and interfere with chemotherapy drugs killing cancer cells. Cancer-related sicknesses such as weight loss, bone weakening, and depression have been linked to high levels of IL-6. This study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM. All participating patients will be in the study for about 6 months and will receive siltuximab four (4) times every 3 weeks at a dose of 15mg per kg bodyweight. Siltuximab is given as a 1 hour intravenous infusion, through a small tube that goes directly into the vein. Following this treatment period, patients showing a response, defined as a 50% or higher reduction in M-protein in their blood/urine, may be allowed to continue treatment with siltuximab 15mg/kg every 4 weeks for up to 2 years.
- Conditions
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Plasma Cell Neoplasm
- Being tested
- Siltuximab
- Keywords
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Indolent Multiple Myeloma, QT, Siltuximab, CNTO 328, IL-6, Monoclonal Antibody
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Neoplasms, Plasma Cell, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiltuximabBiological
15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Siltuximab 15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years. Receives: Biological: Siltuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval
Measured: Screening through Week 10
Secondary outcomes (3)
Additional safety evaluations
Measured: 6 months and, if eligible, up to 2 years of extended treatment
Efficacy evaluations
Measured: 6 months and, if eligible, up to 2 years of extended treatment
Pharmacokinetic and Pharmacodynamic evaluations
Measured: 6 months and, if eligible, up to 2 years of extended treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219010
- Sponsor's protocol ID
- CR017452
- Other IDs
- CNTO328SMM1001
- Status last verified
- Jan 2015
- First submitted
- 23 Sep 2010
- Last updated
- 19 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01219010
- Acronym / sponsor ID
- CR017452
- Conditions
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Plasma Cell Neoplasm
- Keywords
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Indolent Multiple Myeloma, QT, Siltuximab, CNTO 328, IL-6, Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Oct 2010 (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 determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.
Detailed description
This is a research study with an experimental drug called siltuximab (also known as CNTO 328). Currently there are studies with siltuximab, completed or ongoing, in patients with blood cancers such as multiple myeloma and Castleman's disease and with solid tumors such as kidney, ovarian and prostate cancer, to see if siltuximab is safe and to determine what effects it has on these types of cancer. This study is being done in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM) to determine if siltuximab has an effect on heart function measured by ECG recordings, and more specifically to determine if siltuximab has any effect on the QT interval. MGUS, SMM and IMM patients usually go on to develop active multiple myeloma which is a type of cancer that affects the blood and bone marrow. The cancer cells in the bone marrow can cause the normal bone marrow cells to breakdown. This can result in low levels of red blood cells (which may make the patient feel tired or fatigued), low levels of white blood cells (which may increase the patient's chances of infections) or low levels of platelets (which may increase risk of bleeding). The cancer cells can cause damage to the normal bone. This can cause bone pain, bone fractures, and can increase the level of calcium in the blood. The cancer cells also make proteins (called M-proteins), which can result in damage to other organs, especially the kidneys. Siltuximab is a chimeric (part mouse and part human) antibody (immunoglobulin that is important for fighting infection). It does this by blocking another small protein called Interleukin 6 (IL-6). The body makes IL-6 naturally, and at normal levels it is important for the inflammatory response. But high levels of IL-6 can help cancer cells grow and interfere with chemotherapy drugs killing cancer cells. Cancer-related sicknesses such as weight loss, bone weakening, and depression have been linked to high levels of IL-6. This study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM. All participating patients will be in the study for about 6 months and will receive siltuximab four (4) times every 3 weeks at a dose of 15mg per kg bodyweight. Siltuximab is given as a 1 hour intravenous infusion, through a small tube that goes directly into the vein. Following this treatment period, patients showing a response, defined as a 50% or higher reduction in M-protein in their blood/urine, may be allowed to continue treatment with siltuximab 15mg/kg every 4 weeks for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Biological: SiltuximabSiltuximab 15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MGUS (measurable serum M-protein < 3 g/dL AND clonal bone marrow plasma cells < 10% without any end organ damage), SMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% without any end organ damage) or IMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% and = 3 lytic bone lesions but no other end organ damage)
- Qualifying ECG results that will be checked by a central laboratory
- Negative urine drug screen for substances of abuse
- Qualifying hematology and chemistry laboratory results.
Key exclusion criteria (8 listed)
- Diagnosis of symptomatic multiple myeloma
- Prior exposure to approved or investigational myeloma treatments
- Prior exposure to agents targeting IL-6 or the IL-6 receptor
- Significant cardiac disease
- Skin condition likely to interfere with ECG electrode placement, breast implant, or thoracic surgery
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 |
|---|---|---|
| Siltuximab15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years. | Biological | 001 |
Primary outcome
QTc interval
Time frame: Screening through Week 10
3 secondary outcomes
Additional safety evaluations
Time frame: 6 months and, if eligible, up to 2 years of extended treatment
Efficacy evaluations
Time frame: 6 months and, if eligible, up to 2 years of extended treatment
Pharmacokinetic and Pharmacodynamic evaluations
Time frame: 6 months and, if eligible, up to 2 years of extended treatment
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 19 Jan 2015.
- A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects with Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple MyelomaLink provided by the sponsor.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Siltuximab in people with Monoclonal Gammopathy of Undetermined Significance and Multiple Myeloma, run by Janssen Research & Development, LLC at 8 sites in 3 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 8 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 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Russia, Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
QTc interval (time frame: Screening through Week 10). 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 19 Jan 2015.