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NCT03269136 · OUTCOME

Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide

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
nanogram/milliliter
Interval / dispersion
Full Range
Time frame
Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)

What was measured

Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.

Analysis population: PK Concentration Analysis Set was defined as all participants randomized and treated who had at least 1 measurable PF-06863135 concentration.

Groups in this outcome

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.

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 1C: PF-06863135 + Lenalidomide SC4
Part 1D: PF-06863135 + Pomalidomide SC9

Reported measurements

Cycle 1 Day 1
Values in nanogram/milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1C: PF-06863135 + Lenalidomide SCNANot reportedNANAMedian, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
Part 1D: PF-06863135 + Pomalidomide SCNANot reportedNANAMedian, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
Cycle 1 Day 8
Values in nanogram/milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1C: PF-06863135 + Lenalidomide SC70.70Not reported70.770.7Not reported
Part 1D: PF-06863135 + Pomalidomide SC13.60Not reported0.00057.8Not reported
Cycle 1 Day 15
Values in nanogram/milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1C: PF-06863135 + Lenalidomide SC70.60Not reported70.670.6Not reported
Part 1D: PF-06863135 + Pomalidomide SC32.70Not reported0.00049.1Not reported
Cycle 2 Day 15
Values in nanogram/milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1C: PF-06863135 + Lenalidomide SC36.70Not reported20.2234Not reported
Part 1D: PF-06863135 + Pomalidomide SC0.0000Not reported0.0007.41Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.7
        upper Limit
        70.7
        value
        70.70
      2. group Id
        OG001
        lower Limit
        0.000
        upper Limit
        57.8
        value
        13.60
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.6
        upper Limit
        70.6
        value
        70.60
      2. group Id
        OG001
        lower Limit
        0.000
        upper Limit
        49.1
        value
        32.70
    title
    Cycle 1 Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.2
        upper Limit
        234
        value
        36.70
      2. group Id
        OG001
        lower Limit
        0.000
        upper Limit
        7.41
        value
        0.0000
    title
    Cycle 2 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.
dispersion Type
Full Range
groups
  1. description
    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.
    id
    OG000
    title
    Part 1C: PF-06863135 + Lenalidomide SC
  2. description
    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.
    id
    OG001
    title
    Part 1D: PF-06863135 + Pomalidomide SC
param Type
MEDIAN
population Description
PK Concentration Analysis Set was defined as all participants randomized and treated who had at least 1 measurable PF-06863135 concentration.
reporting Status
POSTED
time Frame
Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)
title
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide
type
SECONDARY
unit Of Measure
nanogram/milliliter

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Preserved source evidence · Not medical advice