Smoldering Multiple MyelomaPhase 2NCT01838369
A Phase II Study of BI-505 in Smoldering Multiple Myeloma
A Phase 2 study testing BI-505 in people with Smoldering Multiple Myeloma, run by BioInvent International AB at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- BI-505
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Dec 2014
- 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
- Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:
- Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent.
- Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.
- Male or female, 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
Who cannot join
- Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.
- Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.
- Severe other conditions.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Hemtaology, Skåne University Hospital
Lund, SE-22185
About this study
Official title: A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- BI-505
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-505Drug
| Study group | Role | What they receive |
|---|---|---|
| BI-505 | Experimental | Not described Receives: Drug: BI-505 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria
Measured: M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.
Secondary outcomes (4)
The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.
Safety will be assessed by measuring the following clinical safety parameters; Adverse events, vital signs, clinical laboratory tests, ECG and immunogenicity.
Measured: At each visit and up to 28 days after the last dose.
The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.
Measured: Up to 28 days after the last dose.
The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.
Measured: Up to 28 days after the last dose.
The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.
Measured: Prior to first dose and at 28 days after the final dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoldering 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioInvent International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Hansson, MD, PhD, Principal investigator, Department of Hematology,Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838369
- Sponsor's protocol ID
- 12-BI-505-02
- Status last verified
- May 2015
- First submitted
- 26 Mar 2013
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Wichert S, Juliusson G, Johansson A, Sonesson E, Teige I, Wickenberg AT, Frendeus B, Korsgren M, Hansson M. A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma. PLoS One. 2017 Feb 3;12(2):e0171205. doi: 10.1371/journal.pone.0171205. eCollection 2017.
PubMed 28158311
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01838369
- Acronym / sponsor ID
- 12-BI-505-02
- Conditions
- Smoldering Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BioInvent International ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Apr 2013 (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 investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI-505 | Experimental | Drug: BI-505 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:
- Male or female, 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.
- Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.
- Severe other conditions.
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 |
|---|---|---|
| BI-505 | Drug | BI-505 |
Primary outcome
To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria
Time frame: M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.
4 secondary outcomes
The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.
Time frame: At each visit and up to 28 days after the last dose.
The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.
Time frame: Up to 28 days after the last dose.
The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.
Time frame: Up to 28 days after the last dose.
The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.
Time frame: Prior to first dose and at 28 days after the final dose.
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 28158311Wichert S, Juliusson G, Johansson A, Sonesson E, Teige I, Wickenberg AT, Frendeus B, Korsgren M, Hansson M. A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with BI-505, a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with smoldering multiple myeloma. PLoS One. 2017 Feb 3;12(2):e0171205. doi: 10.1371/journal.pone.0171205. eCollection 2017.
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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.
Markus Hansson, MD, PhD principal investigator
Department of Hematology,Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI-505 in people with Smoldering Multiple Myeloma, run by BioInvent International AB at 1 site in Sweden.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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 assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria (time frame: M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838369, which also lists 1 linked publication.
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 11 Jan 2023.