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

January 10, 2023 updated by: BioInvent International AB

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI-505
Drug: BI-505

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Safety will be assessed by measuring the following clinical safety parameters; Adverse events, vital signs, clinical laboratory tests, ECG and immunogenicity.
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.
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.
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.
Prior to first dose and at 28 days after the final dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioInvent International AB

Investigators

  • Principal Investigator: Markus Hansson, MD, PhD, Department of Hematology,Skåne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-BI-505-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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