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

March 10, 2020 updated by: BioInvent International AB

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

N/A study is closed

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HDM+ASCT
Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
Other: High dose melphalan
High dose melphalan (HDM)
Other: Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
Experimental: BI-505
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
Other: High dose melphalan
High dose melphalan (HDM)
Other: Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)
Biological: BI-505
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients
Time Frame: Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
UNK
Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT.
Time Frame: At Day 100 after ASCT
UNK
At Day 100 after ASCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Day 100 after ASCT
UNK
Day 100 after ASCT
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.
Time Frame: At one year and up to three years after ASCT
UNK
At one year and up to three years after ASCT
Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline.
Time Frame: Day 100
UNK
Day 100
Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT
Time Frame: Prior to HDM + ASCT (from Day -17 until Day 0)
UNK
Prior to HDM + ASCT (from Day -17 until Day 0)
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
Time Frame: Day 100 compared to Baseline (Day -17 and Day -2)
UNK
Day 100 compared to Baseline (Day -17 and Day -2)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax
Time Frame: 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)
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
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax
Time Frame: 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)
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
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC
Time Frame: 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)
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
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL
Time Frame: 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)
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
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss
Time Frame: 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)
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
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2
Time Frame: 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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioInvent International AB

Investigators

  • Principal Investigator: Alfred Garfall, MD, Div of Hema/Onc, Dept.of Med, Perelman Center Advanced Med, Philadelphia PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-BI-505-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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