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Trial record 1 of 1 for:    NCT02756728
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A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02756728
Recruitment Status : Terminated (Full clinical hold from FDA)
First Posted : April 29, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: BI-505 Other: High dose melphalan Other: Autologous stem cell transplantation Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


Arms and Interventions

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
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)
Other: Autologous stem cell transplantation
Autologous stem cell transplantation (ASCT)


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT [ Time Frame: Prior to HDM + ASCT (from Day -17 until Day 0) ]
  5. 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) ]
  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756728


Locations
United States, Pennsylvania
Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
BioInvent International AB
Investigators
Principal Investigator: Alfred Garfall, MD Division of Hematology/Oncology, Department of Medicine, Perelman Center for Advanced Medicine, Philadelphia PA
More Information

Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT02756728     History of Changes
Other Study ID Numbers: 15-BI-505-03
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs