Clinical trial NCT01838369: A Phase II Study of BI-505 in Smoldering Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Smoldering Multiple Myeloma
Lead sponsor: BioInvent International AB
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
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:
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.
measure: The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.
timeFrame: Up to 28 days after the last dose.
measure: The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.
timeFrame: Up to 28 days after the last dose.
measure: The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.
timeFrame: Prior to first dose and at 28 days after the final dose.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Hemtaology, Skåne University Hospital
Study officials:
affiliation: Department of Hematology,Skåne University Hospital
name: Markus Hansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.