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NCT01001442 · OUTCOME

Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT

Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-07-30

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
Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)

What was measured

The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.

Analysis population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).

Groups in this outcome

BT062 40 mg/m²

40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 50 mg/m²

50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 65 mg/m²

65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 80 mg/m²

80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 100 mg/m²

100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 120 mg/m²

120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 140 mg/m²

140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

BT062 160 mg/m²

160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.

Total

BT062 administration (all dose levels)

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

Analysis denominator · Participants

GroupSource count
BT062 40 mg/m²4
BT062 50 mg/m²3
BT062 65 mg/m²4
BT062 80 mg/m²3
BT062 100 mg/m²4
BT062 120 mg/m²3
BT062 140 mg/m²10
BT062 160 mg/m²4
Total35

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BT062 40 mg/m²0Not reportedNot reportedNot reportedNot reported
BT062 50 mg/m²0Not reportedNot reportedNot reportedNot reported
BT062 65 mg/m²0Not reportedNot reportedNot reportedNot reported
BT062 80 mg/m²0Not reportedNot reportedNot reportedNot reported
BT062 100 mg/m²0Not reportedNot reportedNot reportedNot reported
BT062 120 mg/m²1Not reportedNot reportedNot reportedNot reported
BT062 140 mg/m²2Not reportedNot reportedNot reportedNot reported
BT062 160 mg/m²2Not reportedNot reportedNot reportedNot reported
Total5Not 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        5
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
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      35
    units
    Participants
description
The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.
groups
  1. description
    40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG000
    title
    BT062 40 mg/m²
  2. description
    50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG001
    title
    BT062 50 mg/m²
  3. description
    65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG002
    title
    BT062 65 mg/m²
  4. description
    80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG003
    title
    BT062 80 mg/m²
  5. description
    100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG004
    title
    BT062 100 mg/m²
  6. description
    120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG005
    title
    BT062 120 mg/m²
  7. description
    140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG006
    title
    BT062 140 mg/m²
  8. description
    160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    OG007
    title
    BT062 160 mg/m²
  9. description
    BT062 administration (all dose levels)
    id
    OG008
    title
    Total
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).
reporting Status
POSTED
time Frame
Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)
title
Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice