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

Phase 2

Terminated

• Conditions: Smoldering Multiple Myeloma
• Interventions: Drug: BI-505

• Registration Number: NCT01838369
• Lead Sponsor: BioInvent International AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI-505	BI-505	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.	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.	Up to 28 days after the last dose.
The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.	Prior to first dose and at 28 days after the final dose.
The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.	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.

Trial Locations

Locations (1)

Department of Hemtaology, Skåne University Hospital; 🇸🇪 Lund, Sweden