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NCT03269136 · OUTCOME

Part 1: DOR as Per IMWG Criteria

PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma · Source last updated 2025-03-18

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months)

What was measured

DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum \& urine \& disappearance of any soft tissue plasmacytomas\&\<5% plasma cells in bone marrow aspirates.VGPR: serum \& urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.

Analysis population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with confirmed objective response.

Groups in this outcome

Part 1: PF-06863135 0.1 mcg/kg IV

Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 0.3 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 1 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 3 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 10 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 30 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 50 mcg/kg IV

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 80 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 130 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 215 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 360 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 600 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 1000 mcg/kg SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1.1: PF-06863135 Priming Cohort Q1W SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1.1: PF-06863135 Priming Cohort Q2W SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1C: PF-06863135 + Lenalidomide SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1D: PF-06863135 + Pomalidomide SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 Total IV

Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1: PF-06863135 Total SC

Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

Part 1.1: PF-06863135 Total SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Part 1: PF-06863135 0.1 mcg/kg IV0
Part 1: PF-06863135 0.3 mcg/kg IV0
Part 1: PF-06863135 1 mcg/kg IV0
Part 1: PF-06863135 3 mcg/kg IV0
Part 1: PF-06863135 10 mcg/kg IV0
Part 1: PF-06863135 30 mcg/kg IV0
Part 1: PF-06863135 50 mcg/kg IV0
Part 1: PF-06863135 80 mcg/kg SC0
Part 1: PF-06863135 130 mcg/kg SC0
Part 1: PF-06863135 215 mcg/kg SC2
Part 1: PF-06863135 360 mcg/kg SC3
Part 1: PF-06863135 600 mcg/kg SC4
Part 1: PF-06863135 1000 mcg/kg SC5
Part 1.1: PF-06863135 Priming Cohort Q1W SC4
Part 1.1: PF-06863135 Priming Cohort Q2W SC8
Part 1C: PF-06863135 + Lenalidomide SC3
Part 1D: PF-06863135 + Pomalidomide SC7
Part 1: PF-06863135 Total IV0
Part 1: PF-06863135 Total SC14
Part 1.1: PF-06863135 Total SC12

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06863135 215 mcg/kg SC25.3Not reported18.4NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 360 mcg/kg SC13.6Not reported5.4NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 600 mcg/kg SCNANot reported32.2NAThe median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 1000 mcg/kg SCNANot reported6.3NAThe median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1.1: PF-06863135 Priming Cohort Q1W SC6.7Not reported3.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1.1: PF-06863135 Priming Cohort Q2W SC17.1Not reported10.6NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1C: PF-06863135 + Lenalidomide SC14.9Not reported11.8NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1D: PF-06863135 + Pomalidomide SC8.3Not reported2.9NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 Total SC32.2Not reported7.0NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1.1: PF-06863135 Total SC13.3Not reported6.3NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG009
        lower Limit
        18.4
        upper Limit
        NA
        value
        25.3
      2. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG010
        lower Limit
        5.4
        upper Limit
        NA
        value
        13.6
      3. comment
        The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG011
        lower Limit
        32.2
        upper Limit
        NA
        value
        NA
      4. comment
        The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG012
        lower Limit
        6.3
        upper Limit
        NA
        value
        NA
      5. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG013
        lower Limit
        3.7
        upper Limit
        NA
        value
        6.7
      6. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG014
        lower Limit
        10.6
        upper Limit
        NA
        value
        17.1
      7. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG015
        lower Limit
        11.8
        upper Limit
        NA
        value
        14.9
      8. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG016
        lower Limit
        2.9
        upper Limit
        NA
        value
        8.3
      9. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG018
        lower Limit
        7.0
        upper Limit
        NA
        value
        32.2
      10. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG019
        lower Limit
        6.3
        upper Limit
        NA
        value
        13.3
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
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      4
    units
    Participants
description
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum \& urine \& disappearance of any soft tissue plasmacytomas\&\<5% plasma cells in bone marrow aspirates.VGPR: serum \& urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG000
    title
    Part 1: PF-06863135 0.1 mcg/kg IV
  2. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG001
    title
    Part 1: PF-06863135 0.3 mcg/kg IV
  3. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG002
    title
    Part 1: PF-06863135 1 mcg/kg IV
  4. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG003
    title
    Part 1: PF-06863135 3 mcg/kg IV
  5. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG004
    title
    Part 1: PF-06863135 10 mcg/kg IV
  6. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG005
    title
    Part 1: PF-06863135 30 mcg/kg IV
  7. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG006
    title
    Part 1: PF-06863135 50 mcg/kg IV
  8. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG007
    title
    Part 1: PF-06863135 80 mcg/kg SC
  9. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG008
    title
    Part 1: PF-06863135 130 mcg/kg SC
  10. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG009
    title
    Part 1: PF-06863135 215 mcg/kg SC
  11. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG010
    title
    Part 1: PF-06863135 360 mcg/kg SC
  12. description
    Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
    id
    OG011
    title
    Part 1: PF-06863135 600 mcg/kg SC
param Type
MEDIAN
population Description
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with confirmed objective response.
reporting Status
POSTED
time Frame
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months)
title
Part 1: DOR as Per IMWG Criteria
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice