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

NCT01838369 | Terminated Phase 2

• 1 other identifier: 12-BI-505-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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 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 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.

Study Arms (1)

BI-505

EXPERIMENTAL

Drug: BI-505

Interventions

BI-505 DRUG

BI-505

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioInvent International AB: lead

Study Sites (1)

Department of Hemtaology, Skåne University Hospital

Lund, SE-22185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 28158311 DERIVED

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Markus Hansson, MD, PhD

  Department of Hematology,Skåne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 24, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 11, 2023

Record last verified: 2015-05

Locations

SE (1)