Multiple Myeloma
Conditions
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
Interventions
BIOLOGICALBI-505
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months
OTHERHigh dose melphalan
High dose melphalan (HDM)
OTHERAutologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
Sponsors
BioInvent International AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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) |
Countries
United States
Outcome results
None listed