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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

N/A study is closed

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioInvent International AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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