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NCT03269136 · OUTCOME

Part 1: Progression Free Survival (PFS) 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 start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)

What was measured

PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.

Analysis population: mITT analysis set included all participants who have received at least one dose of study treatment.

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 IV2
Part 1: PF-06863135 0.3 mcg/kg IV3
Part 1: PF-06863135 1 mcg/kg IV2
Part 1: PF-06863135 3 mcg/kg IV3
Part 1: PF-06863135 10 mcg/kg IV2
Part 1: PF-06863135 30 mcg/kg IV5
Part 1: PF-06863135 50 mcg/kg IV6
Part 1: PF-06863135 80 mcg/kg SC6
Part 1: PF-06863135 130 mcg/kg SC4
Part 1: PF-06863135 215 mcg/kg SC4
Part 1: PF-06863135 360 mcg/kg SC4
Part 1: PF-06863135 600 mcg/kg SC6
Part 1: PF-06863135 1000 mcg/kg SC6
Part 1.1: PF-06863135 Priming Cohort Q1W SC7
Part 1.1: PF-06863135 Priming Cohort Q2W SC13
Part 1C: PF-06863135 + Lenalidomide SC4
Part 1D: PF-06863135 + Pomalidomide SC9
Part 1: PF-06863135 Total IV23
Part 1: PF-06863135 Total SC30
Part 1.1: PF-06863135 Total SC20

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06863135 0.1 mcg/kg IV0.4Not reported0.3NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 0.3 mcg/kg IV0.7Not reported0.3NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 1 mcg/kg IV1.1Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 3 mcg/kg IV1.7Not reported0.6NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 10 mcg/kg IV1.6Not reported0.6NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 30 mcg/kg IV1.6Not reported0.6NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 50 mcg/kg IV2.9Not reported0.8NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 80 mcg/kg SC1.0Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 130 mcg/kg SC1.0Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 215 mcg/kg SC19.1Not reported4.8NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 360 mcg/kg SC10.2Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 600 mcg/kg SC32.9Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 1000 mcg/kg SC8.0Not reported0.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1.1: PF-06863135 Priming Cohort Q1W SC7.6Not reported3.9NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1.1: PF-06863135 Priming Cohort Q2W SC12.7Not reported0.5NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1C: PF-06863135 + Lenalidomide SC18.1Not reported1.7NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1D: PF-06863135 + Pomalidomide SC6.7Not reported0.9NAThe upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Part 1: PF-06863135 Total IV1.4Not reported0.62.6Not reported
Part 1: PF-06863135 Total SC4.8Not reported1.114.4Not reported
Part 1.1: PF-06863135 Total SC12.2Not reported3.919.2Not reported
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
        OG000
        lower Limit
        0.3
        upper Limit
        NA
        value
        0.4
      2. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        0.3
        upper Limit
        NA
        value
        0.7
      3. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        0.7
        upper Limit
        NA
        value
        1.1
      4. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        0.6
        upper Limit
        NA
        value
        1.7
      5. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        0.6
        upper Limit
        NA
        value
        1.6
      6. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        0.6
        upper Limit
        NA
        value
        1.6
      7. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG006
        lower Limit
        0.8
        upper Limit
        NA
        value
        2.9
      8. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG007
        lower Limit
        0.7
        upper Limit
        NA
        value
        1.0
      9. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG008
        lower Limit
        0.7
        upper Limit
        NA
        value
        1.0
      10. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG009
        lower Limit
        4.8
        upper Limit
        NA
        value
        19.1
      11. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG010
        lower Limit
        0.7
        upper Limit
        NA
        value
        10.2
      12. comment
        The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
        group Id
        OG011
        lower Limit
        0.7
        upper Limit
        NA
        value
        32.9
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      6
    9. group Id
      OG008
      value
      4
    10. group Id
      OG009
      value
      4
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      6
    units
    Participants
description
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.
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.
reporting Status
POSTED
time Frame
From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)
title
Part 1: Progression Free Survival (PFS) as Per IMWG Criteria
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice