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

Primary Purpose

Smoldering Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
BI-505
Sponsored by
BioInvent International AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoldering Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Hemtaology, Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BI-505

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.
The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.
The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.

Full Information

First Posted
March 26, 2013
Last Updated
January 10, 2023
Sponsor
BioInvent International AB
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1. Study Identification

Unique Protocol Identification Number
NCT01838369
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioInvent International AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoldering Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI-505
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI-505
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.
Description
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Hansson, MD, PhD
Organizational Affiliation
Department of Hematology,Skåne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hemtaology, Skåne University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28158311
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.
Results Reference
derived

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

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