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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Smoldering Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Markus Hansson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology,Skåne University Hospital

Authority:

Sweden: Medical Products Agency

Study ID:

12-BI-505-02

NCT ID:

NCT01838369

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

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

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