A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
NCT ID: NCT02756728
Last Updated: 2020-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2016-05-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HDM+ASCT
Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
High dose melphalan
High dose melphalan (HDM)
Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
BI-505
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
BI-505
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months
High dose melphalan
High dose melphalan (HDM)
Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
Interventions
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BI-505
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months
High dose melphalan
High dose melphalan (HDM)
Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
Eligibility Criteria
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Inclusion Criteria
* Subjects must have adequate vital organ function and functional status for HDM + ASCT
* Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
* At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.
* Subjects must have measurable disease according to one of the following criteria:
1. Serum M-spike ≥0.1 g/dl
2. Urine M-spike \>200 mg in a 24-hour urine collection
3. Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
* At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy
Exclusion Criteria
* Current active infections, including HIV and hepatitis C and B
* Autoimmune disease requiring ongoing immunosuppressive therapy.
* History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
* History of transient ischemic attack or stroke.
* At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.
18 Years
70 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
Responsible Party
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Principal Investigators
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Alfred Garfall, MD
Role: PRINCIPAL_INVESTIGATOR
Div of Hema/Onc, Dept.of Med, Perelman Center Advanced Med, Philadelphia PA
Locations
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Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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15-BI-505-03
Identifier Type: -
Identifier Source: org_study_id
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