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

Smoldering Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01838369
• Other study ID #: 12-BI-505-02
• Status: Terminated
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: BioInvent International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Smoldering Multiple Myeloma

Intervention

Drug:
• BI-505

Locations

Country	Name	City	State
Sweden	Department of Hemtaology, Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
BioInvent International AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At each visit and up to 28 days after the last dose.
Secondary	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.
Secondary	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.
Secondary	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.