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NCT05911321 · OUTCOME

Overall Response Rate (ORR)

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM · Source last updated 2026-06-09

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
Up to 12 weeks

What was measured

Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were reported. Complete response (CR) requires negative serum and urine immunofixation, disappearance of plasmacytomas, and \<5% bone marrow plasma cells; stringent complete response (sCR) requires CR plus a normal free light chain ratio and no clonal plasma cells in bone marrow. Very good partial response (VGPR) is defined as M-protein detectable by immunofixation but not electrophoresis, or a ≥90% reduction in serum M-protein with urine M-protein \<100 mg/24h. Partial response (PR) is defined as a ≥50% reduction in serum M-protein and a ≥90% reduction in 24-hour urine M-protein (or to \<200 mg/24h), with a ≥50% reduction in plasmacytomas if present at baseline.

Analysis population: Participants received study treatment for up to 12 weeks, at which point tumor response was assessed.

Groups in this outcome

Experimental: Single Arm

Subjects with relapsed or refractory multiple myeloma receiving the study treatment.

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

Analysis denominator · Participants

GroupSource count
Experimental: Single Arm5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Single Arm4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were reported. Complete response (CR) requires negative serum and urine immunofixation, disappearance of plasmacytomas, and \<5% bone marrow plasma cells; stringent complete response (sCR) requires CR plus a normal free light chain ratio and no clonal plasma cells in bone marrow. Very good partial response (VGPR) is defined as M-protein detectable by immunofixation but not electrophoresis, or a ≥90% reduction in serum M-protein with urine M-protein \<100 mg/24h. Partial response (PR) is defined as a ≥50% reduction in serum M-protein and a ≥90% reduction in 24-hour urine M-protein (or to \<200 mg/24h), with a ≥50% reduction in plasmacytomas if present at baseline.
groups
  1. description
    Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
    id
    OG000
    title
    Experimental: Single Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants received study treatment for up to 12 weeks, at which point tumor response was assessed.
reporting Status
POSTED
time Frame
Up to 12 weeks
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice