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NCT03340883 · OUTCOME

Safety (Phase 1)

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) · Source last updated 2021-04-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
28 days following first administration of BION-1301

What was measured

Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent

Analysis population: Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.

Groups in this outcome

BION-1301 50 mg Q2W

50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.

BION-1301 150 mg Q2W

150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 450 mg Q2W

450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg Q2W

1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 2700 mg Q2W

2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg QW*8W->Q2W

1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
BION-1301 50 mg Q2W4
BION-1301 150 mg Q2W3
BION-1301 450 mg Q2W4
BION-1301 1350 mg Q2W4
BION-1301 2700 mg Q2W3
BION-1301 1350 mg QW*8W->Q2W3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BION-1301 50 mg Q2W0Not reportedNot reportedNot reportedNot reported
BION-1301 150 mg Q2W0Not reportedNot reportedNot reportedNot reported
BION-1301 450 mg Q2W0Not reportedNot reportedNot reportedNot reported
BION-1301 1350 mg Q2W1Not reportedNot reportedNot reportedNot reported
BION-1301 2700 mg Q2W0Not reportedNot reportedNot reportedNot reported
BION-1301 1350 mg QW*8W->Q2W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities (DLTs) of BION-1301 as a single agent
groups
  1. description
    50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
    id
    OG000
    title
    BION-1301 50 mg Q2W
  2. description
    150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG001
    title
    BION-1301 150 mg Q2W
  3. description
    450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG002
    title
    BION-1301 450 mg Q2W
  4. description
    1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG003
    title
    BION-1301 1350 mg Q2W
  5. description
    2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    OG004
    title
    BION-1301 2700 mg Q2W
  6. description
    1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
    id
    OG005
    title
    BION-1301 1350 mg QW*8W->Q2W
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Analysis Set (all participants who received any amount of study drug) in the Phase 1 part of the study.
reporting Status
POSTED
time Frame
28 days following first administration of BION-1301
title
Safety (Phase 1)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice