A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Biological: BI-505Other: High dose melphalanOther: Autologous stem cell transplantation
- Registration Number
- NCT02756728
- Lead Sponsor
- BioInvent International AB
- Brief Summary
The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.
- Detailed Description
N/A study is closed
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
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Subjects must have adequate vital organ function and functional status for HDM + ASCT
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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.
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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.
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Subjects must have measurable disease according to one of the following criteria:
- Serum M-spike ≥0.1 g/dl
- Urine M-spike >200 mg in a 24-hour urine collection
- Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
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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
- Prior allogeneic or autologous hematopoietic stem cell transplant
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI-505 BI-505 Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation HDM+ASCT High dose melphalan Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation BI-505 High dose melphalan Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation HDM+ASCT Autologous stem cell transplantation Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation BI-505 Autologous stem cell transplantation Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
- Primary Outcome Measures
Name Time Method Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients Adverse events will be assessed within 30 days of ASCT in the safety part of the study. UNK
Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT. At Day 100 after ASCT UNK
- Secondary Outcome Measures
Name Time Method Determine the effect of BI-505 on rate of stringent complete response (sCR) at day 100 in subgroups stratified according to response to initial therapy (+/- VGPR). Day 100 after ASCT UNK
Determine the effect of BI-505 administered in conjunction with HDM + ASCT on IMWG response category (PR, VGPR, CR, sCR) at one year post-ASCT and progression-free survival. At one year and up to three years after ASCT UNK
Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline. Day 100 UNK
Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT Prior to HDM + ASCT (from Day -17 until Day 0) UNK
Evaluate bone marrow immune cell composition and phenotype, including macrophage infiltration and expression of intracellular adhesion molecule (ICAM)-1 expression on multiple myeloma plasma cells, as potential biomarkers of response to BI-505 Day 100 compared to Baseline (Day -17 and Day -2) UNK
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Maximum Plasma Concentration (Cmax)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Time to reach Cmax (Tmax)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Area under the curve (AUC)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Clearance (CL)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Volume of distribution at steady state (Vss)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2 All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123 Elimination half-life (t1/2)
Trial Locations
- Locations (1)
Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States