Clinical trial · Interventional
A Phase II Study of BI-505 in Smoldering Multiple Myeloma
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
NCT01838369CI-TRIAL-00063144terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI-505 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BI-505
- interventionNames
- Drug: BI-505
Primary outcomes (1)
- 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
- timeFrame
- 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)
- measure
- The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.
- timeFrame
- At each visit and up to 28 days after the last dose.
- description
- Safety will be assessed by measuring the following clinical safety parameters; Adverse events, vital signs, clinical laboratory tests, ECG and immunogenicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (1)
- DERIVEDWichert 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. PMID 28158311