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NCT05511428 · OUTCOME

Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7

Home Based Daratumumab Administration for Patients With Multiple Myeloma · Source last updated 2025-11-21

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

Measure
MEAN
Unit
scores on a scale (0-100)
Interval / dispersion
Standard Deviation
Time frame
At Visit 7, Day 169

What was measured

Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

Analysis population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Groups in this outcome

Treatment (daratumumab and hyaluronidase-fihj)

Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Treatment (daratumumab and hyaluronidase-fihj)16

Reported measurements

Source class 1
Values in scores on a scale (0-100) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (daratumumab and hyaluronidase-fihj)69.318.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.4
        value
        69.3
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
    id
    OG000
    title
    Treatment (daratumumab and hyaluronidase-fihj)
param Type
MEAN
population Description
Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome.
reporting Status
POSTED
time Frame
At Visit 7, Day 169
title
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7
type
SECONDARY
unit Of Measure
scores on a scale (0-100)

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

Preserved source evidence · Not medical advice