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NCT02289222 · OUTCOME

PD-LI Expression On Myeloma Cells

1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)

What was measured

The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients' bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.

Analysis population: Data were analyzed for 29 samples.

Groups in this outcome

Pomalidomide, Dexamethasone & MK-3475

Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly

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

Analysis denominator · Participants

GroupSource count
Pomalidomide, Dexamethasone & MK-347529

Reported measurements

Negative
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide, Dexamethasone & MK-347510Not reportedNot reportedNot reportedNot reported
Weak Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide, Dexamethasone & MK-34756Not reportedNot reportedNot reportedNot reported
Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide, Dexamethasone & MK-347513Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Negative
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Weak Positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients' bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.
groups
  1. description
    Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly
    id
    OG000
    title
    Pomalidomide, Dexamethasone & MK-3475
param Type
COUNT_OF_PARTICIPANTS
population Description
Data were analyzed for 29 samples.
reporting Status
POSTED
time Frame
Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)
title
PD-LI Expression On Myeloma Cells
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice