A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02756728
• Other study ID #: 15-BI-505-03
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2020
• Source: BioInvent International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

N/A study is closed

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• BI-505
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months

Other:
• High dose melphalan
High dose melphalan (HDM)
• Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)

Locations

Country	Name	City	State
United States	Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
BioInvent International AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients	UNK	Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
Primary	Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT.	UNK	At Day 100 after ASCT
Secondary	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).	UNK	Day 100 after ASCT
Secondary	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.	UNK	At one year and up to three years after ASCT
Secondary	Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline.	UNK	Day 100
Secondary	Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT	UNK	Prior to HDM + ASCT (from Day -17 until Day 0)
Secondary	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	UNK	Day 100 compared to Baseline (Day -17 and Day -2)
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax	Maximum Plasma Concentration (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
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax	Time to reach Cmax (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
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC	Area under the curve (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
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL	Clearance (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
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss	Volume of distribution at steady state (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
Secondary	Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2	Elimination half-life (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