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NCT02514239 · OUTCOME

Duration of Objective Response - on Treatment

Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients · Source last updated 2022-02-24

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
From start of treatment till end of trial (EOT) visit, up to 61 weeks.

What was measured

For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.

Analysis population: All patients who were administered trial medication and showed an objective response.

Groups in this outcome

Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)

Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (3.2 μg/d)

Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (6.5 μg/d)

Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (13 μg/d)

Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (25 μg/d)

Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (50 μg/d)

Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (100 μg/d)

Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (200 μg/d)

Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (400 μg/d)

Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

Intravenous Infusion of BI 836909 (800 μg/d)

Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.

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

Analysis denominator · Participants

GroupSource count
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)0
Intravenous Infusion of BI 836909 (3.2 μg/d)0
Intravenous Infusion of BI 836909 (6.5 μg/d)1
Intravenous Infusion of BI 836909 (13 μg/d)0
Intravenous Infusion of BI 836909 (25 μg/d)0
Intravenous Infusion of BI 836909 (50 μg/d)1
Intravenous Infusion of BI 836909 (100 μg/d)1
Intravenous Infusion of BI 836909 (200 μg/d)1
Intravenous Infusion of BI 836909 (400 μg/d)7
Intravenous Infusion of BI 836909 (800 μg/d)2

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Intravenous Infusion of BI 836909 (6.5 μg/d)NANot reportedNANAInsufficient number of participants with events.
Intravenous Infusion of BI 836909 (50 μg/d)NANot reportedNANAInsufficient number of participants with events.
Intravenous Infusion of BI 836909 (100 μg/d)NANot reportedNANAInsufficient number of participants with events.
Intravenous Infusion of BI 836909 (200 μg/d)NANot reportedNANAInsufficient number of participants with events.
Intravenous Infusion of BI 836909 (400 μg/d)NANot reported4.63NAEstimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
Intravenous Infusion of BI 836909 (800 μg/d)NANot reportedNANAInsufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Insufficient number of participants with events.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Insufficient number of participants with events.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
        group Id
        OG008
        lower Limit
        4.63
        upper Limit
        NA
        value
        NA
      6. comment
        Insufficient number of participants with events.
        group Id
        OG009
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      7
    10. group Id
      OG009
      value
      2
    units
    Participants
description
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG000
    title
    Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
  2. description
    Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG001
    title
    Intravenous Infusion of BI 836909 (3.2 μg/d)
  3. description
    Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG002
    title
    Intravenous Infusion of BI 836909 (6.5 μg/d)
  4. description
    Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG003
    title
    Intravenous Infusion of BI 836909 (13 μg/d)
  5. description
    Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG004
    title
    Intravenous Infusion of BI 836909 (25 μg/d)
  6. description
    Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG005
    title
    Intravenous Infusion of BI 836909 (50 μg/d)
  7. description
    Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG006
    title
    Intravenous Infusion of BI 836909 (100 μg/d)
  8. description
    Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG007
    title
    Intravenous Infusion of BI 836909 (200 μg/d)
  9. description
    Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG008
    title
    Intravenous Infusion of BI 836909 (400 μg/d)
  10. description
    Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
    id
    OG009
    title
    Intravenous Infusion of BI 836909 (800 μg/d)
param Type
MEDIAN
population Description
All patients who were administered trial medication and showed an objective response.
reporting Status
POSTED
time Frame
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
title
Duration of Objective Response - on Treatment
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice