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NCT05511428 · OUTCOME

Number of Participants With Medication Adherence in Home Setting During Cycle 4

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At Visit 4,Day 85

What was measured

Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).

Analysis population: Participants who received at least one dose in the home setting during cycle 4.

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)19

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (daratumumab and hyaluronidase-fihj)19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).
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
COUNT_OF_PARTICIPANTS
population Description
Participants who received at least one dose in the home setting during cycle 4.
reporting Status
POSTED
time Frame
At Visit 4,Day 85
title
Number of Participants With Medication Adherence in Home Setting During Cycle 4
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice