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NCT03340883 · REGISTRY CONDITION SEARCH

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2021-04-01

This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior systemic therapies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Safety (Phase 1)

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outcome · POSTED

Recommended Phase 2 Dose (Phase 1)

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outcome · POSTED

Biomarkers (Phase 1 and 2)

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outcome · POSTED

Bioanalytical Measures (Phase 1 and Phase 2)

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outcome · POSTED

Safety Profile (Phase 2)

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outcome · POSTED

Response Rate (Phase 2)

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outcome · POSTED

Progression-Free Survival (Phase 2)

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outcome · POSTED

Overall Survival (Phase 2)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Key Inclusion Criteria: Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol: 1. Male or female, aged ≥ 18 years 2. Confirmed diagnosis of MM per IMWG criteria 3. Measurable disease as defined by one or more of the following: * Serum M-protein ≥ 0.5 g/dL * Urine M-protein ≥ 200 mg/24 hours * Serum Free Light Chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal * In cases where SPEP is unreliable, serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) is acceptable 4. Relapsed or refractory (Rajkumar, 2011) to 3 or more different prior lines of therapy for MM, including immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to established therapy known to provide clinical benefit. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1 6. Adequate organ and marrow function at Screening, as defined by the study protocol. Key Exclusion Criteria: 1. Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenstrom's macroglobulinemia, or IgM myeloma 2. Active plasma cell leukemia (˃ 2.0 × 109/L circulating plasma cells by standard differential) 3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 4. Prior treatment directed to B-cell Activating Factor (BAFF; BLyS), B-cell Maturation Antigen (BCMA;TNFSF17) or Transmembrane Activator and CAML interactor (TACI; TNFSF13B), including antibodies or BCMA- or TACI-directed Chimeric Antigen Receptor (CAR)-T cell therapy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
    intervention Names
    1. Biological: BION-1301
    label
    BION-1301
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. BION-1301
    description
    a solution for intravenous (IV) administration, diluted and administered Q2W
    name
    BION-1301
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
intervention Model Description
Single arm study
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
    measure
    Safety (Phase 1)
    time Frame
    28 days following first administration of BION-1301
  2. description
    Recommended Phase 2 Dose RP2D of BION-1301 when administered as a single-agent
    measure
    Recommended Phase 2 Dose (Phase 1)
    time Frame
    Approximately 2 years
  3. description
    Biomarkers such as soluble a proliferation inducing ligand (APRIL; TNFSF13); soluble B cell maturation antigen (BCMA; TNFRSF17)
    measure
    Biomarkers (Phase 1 and 2)
    time Frame
    Baseline and approximately 2 years
  4. description
    Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline
    measure
    Bioanalytical Measures (Phase 1 and Phase 2)
    time Frame
    Baseline and approximately 2 years
  5. description
    BION-1301 safety profile based on incidence of TEAEs (treatment emergent adverse events), changes in safety parameters, and unacceptable toxicities
    measure
    Safety Profile (Phase 2)
    time Frame
    28 days
  6. description
    Objective response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)
    measure
    Response Rate (Phase 2)
    time Frame
    Approximately 30 months
  7. description
    Progression-free survival (PFS) defined as time from first dose of study drug to date of first tumor progression or death due to any cause
    measure
    Progression-Free Survival (Phase 2)
    time Frame
    Approximately 30 months
  8. description
    Overall survival (OS) defined as the time from first dose of study drug to date of death due to any cause
    measure
    Overall Survival (Phase 2)
    time Frame
    Approximately 30 months
Full study description
brief Summary
This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior systemic therapies.
detailed Description
An open-label, multi-center, dose-selection Phase 1/2 study (also referred to as ADU-CL-16) evaluating BION-1301, a humanized monoclonal antibody directed against APRIL for the treatment of relapsed or refractory MM. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and initial clinical activity of BION-1301 administered as a single agent. The study will be conducted in 2 parts. Phase 1 is dose escalation and seeks to determine the recommended phase 2 dose (RP2D). Once an RP2D is identified, Phase 2 of the study will open and continue to evaluate the safety and preliminary efficacy of BION-1301 administered at selected dose level(s). The population for this study will consist of adults with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies. BION-1301 will be administered in 28-day cycles; the dosing interval will be once every two weeks (Q2W).
Source references
references
  1. citation
    Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.
    pmid
    21292775
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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      query cond
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      source file
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    Preserved source evidence · Not medical advice