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

NCT02756728 | Terminated Phase 1

• 1 other identifier: 15-BI-505-03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (11)

• 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).

  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.

  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.

  Day 100

• Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT

  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

  Day 100 compared to Baseline (Day -17 and Day -2)

Study Arms (2)

HDM+ASCT

ACTIVE COMPARATOR

Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation

Other: High dose melphalan; Other: Autologous stem cell transplantation

BI-505

EXPERIMENTAL

Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation

Biological: BI-505; Other: High dose melphalan; Other: Autologous stem cell transplantation

Interventions

BI-505 BIOLOGICAL

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

BI-505

High dose melphalan OTHER

High dose melphalan (HDM)

BI-505; HDM+ASCT

Autologous stem cell transplantation OTHER

Autologous stem cell transplantation (ASCT)

BI-505; HDM+ASCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BioInvent International AB: lead

Study Sites (1)

Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Alfred Garfall, MD

  Div of Hema/Onc, Dept.of Med, Perelman Center Advanced Med, Philadelphia PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)