TerminatedNCT01838369Updated Jan 11, 2023

A Phase II Study of BI-505 in Smoldering Multiple Myeloma

A Phase 2 interventional study of BI-505 in Smoldering Multiple Myeloma, sponsored by BioInvent International AB. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.

Sponsored by BioInvent International AB · Phase 2, Interventional, and Treatment

Why this study was terminated

Sponsor's decision

Phase: Phase 2
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.

Conditions studied

Smoldering Multiple Myeloma

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 4 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

BioInvent International AB is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Experimental
BI-505
Drug: BI-505

Interventions

DrugBI-505

What researchers measure

Primary outcomes

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.

Secondary outcomes

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.
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.

Study locations

1 site

Department of Hemtaology, Skåne University Hospital
Lund, SE-22185, Sweden

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01838369
Lead sponsor: BioInvent International AB
Responsible party: Sponsor
First posted: Apr 24, 2013
Start date: Mar 2013
Primary completion: Dec 2014
Completion: Dec 2014
Last update: Jan 11, 2023

Study contacts

Markus Hansson, MD, PhD

principal investigator · Department of Hematology,Skåne University Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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