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NCT03269136 · OUTCOME

Part 2: CRR 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)

What was measured

CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; 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 2A: PF-06863135 SC

Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.

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 2A: PF-06863135 SC15

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2A: PF-06863135 SC33.3Not reported15.258.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.2
        upper Limit
        58.3
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; 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 MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection 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.
    id
    OG000
    title
    Part 2A: PF-06863135 SC
param Type
NUMBER
population Description
mITT analysis set included all participants who have received at least one dose of study treatment.
reporting Status
POSTED
time Frame
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
title
Part 2: CRR as Per IMWG Criteria
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice