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

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ClinicalTrials.gov Identifier: NCT01838369
Recruitment Status : Terminated (Sponsor's decision)
First Posted : April 24, 2013
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoldering Multiple Myeloma Drug: BI-505 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: BI-505 Drug: BI-505



Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. 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.

  2. 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. ]
  3. 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. ]
  4. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838369


Locations
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Sweden
Department of Hemtaology, Skåne University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
BioInvent International AB
Investigators
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Principal Investigator: Markus Hansson, MD, PhD Department of Hematology,Skåne University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT01838369    
Other Study ID Numbers: 12-BI-505-02
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions
Hypergammaglobulinemia