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NCT03340883 · OUTCOME

Response Rate (Phase 2)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Approximately 30 months

What was measured

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)

Analysis population: Study was terminated early and Phase 2 was not enrolled. Objective response rate was not assessed.

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 Q2W0
BION-1301 150 mg Q2W0
BION-1301 450 mg Q2W0
BION-1301 1350 mg Q2W0
BION-1301 2700 mg Q2W0
BION-1301 1350 mg QW*8W->Q2W0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
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)
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
population Description
Study was terminated early and Phase 2 was not enrolled. Objective response rate was not assessed.
reporting Status
POSTED
time Frame
Approximately 30 months
title
Response Rate (Phase 2)
type
PRIMARY

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

Preserved source evidence · Not medical advice