A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
Stopped early · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT02756728
- Run by
- BioInvent International AB
- People needed
- 5
- Starts
- 2016-05-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2020-03-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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.
- 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
You may not qualify if…
- 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.
Where it is running
- Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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