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NCT03277105 · OUTCOME

Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-04-29

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

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)

What was measured

Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.

Analysis population: ITT population included all the randomized participants. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure and 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point.

Groups in this outcome

Daratumumab IV

Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.

Daratumumab SC

Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.

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

Analysis denominator · Participants

Group	Source count
Daratumumab IV	239
Daratumumab SC	263

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

Group	Source count
Daratumumab IV	227
Daratumumab SC	230

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	70.5	15.98	Not reported	Not reported	Not reported
Daratumumab SC	76.9	14.64	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
Daratumumab IV	226
Daratumumab SC	238

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	72.1	16.72	Not reported	Not reported	Not reported
Daratumumab SC	78.8	14.95	Not reported	Not reported	Not reported

Cycle 1 Day 22

Analysis denominator · Participants

Group	Source count
Daratumumab IV	226
Daratumumab SC	239

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	72.8	16.20	Not reported	Not reported	Not reported
Daratumumab SC	78.7	15.75	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	239
Daratumumab SC	238

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	74.2	16.44	Not reported	Not reported	Not reported
Daratumumab SC	79.7	16.58	Not reported	Not reported	Not reported

Cycle 2 Day 8

Analysis denominator · Participants

Group	Source count
Daratumumab IV	227
Daratumumab SC	232

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	74.8	15.57	Not reported	Not reported	Not reported
Daratumumab SC	80.1	17.24	Not reported	Not reported	Not reported

Cycle 2 Day 15

Analysis denominator · Participants

Group	Source count
Daratumumab IV	228
Daratumumab SC	224

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	74.3	16.94	Not reported	Not reported	Not reported
Daratumumab SC	80.0	17.37	Not reported	Not reported	Not reported

Cycle 2 Day 22

Analysis denominator · Participants

Group	Source count
Daratumumab IV	221
Daratumumab SC	214

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	75.2	16.47	Not reported	Not reported	Not reported
Daratumumab SC	79.3	18.65	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	217
Daratumumab SC	224

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	76.0	17.39	Not reported	Not reported	Not reported
Daratumumab SC	80.4	17.78	Not reported	Not reported	Not reported

Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	205
Daratumumab SC	209

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	76.6	17.22	Not reported	Not reported	Not reported
Daratumumab SC	79.5	19.88	Not reported	Not reported	Not reported

Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	187
Daratumumab SC	188

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	77.1	17.11	Not reported	Not reported	Not reported
Daratumumab SC	79.6	18.95	Not reported	Not reported	Not reported

Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	169
Daratumumab SC	159

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	76.1	17.79	Not reported	Not reported	Not reported
Daratumumab SC	81.9	18.34	Not reported	Not reported	Not reported

Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	150
Daratumumab SC	137

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	78.6	16.01	Not reported	Not reported	Not reported
Daratumumab SC	85.0	16.87	Not reported	Not reported	Not reported

Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	135
Daratumumab SC	127

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.2	15.54	Not reported	Not reported	Not reported
Daratumumab SC	85.0	15.18	Not reported	Not reported	Not reported

Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	121
Daratumumab SC	113

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.8	15.27	Not reported	Not reported	Not reported
Daratumumab SC	85.2	15.03	Not reported	Not reported	Not reported

Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	111
Daratumumab SC	103

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.4	14.73	Not reported	Not reported	Not reported
Daratumumab SC	85.8	13.31	Not reported	Not reported	Not reported

Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	96
Daratumumab SC	94

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.1	15.55	Not reported	Not reported	Not reported
Daratumumab SC	84.8	13.50	Not reported	Not reported	Not reported

Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	83
Daratumumab SC	81

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	80.3	15.88	Not reported	Not reported	Not reported
Daratumumab SC	85.4	14.70	Not reported	Not reported	Not reported

Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	77
Daratumumab SC	76

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.6	16.57	Not reported	Not reported	Not reported
Daratumumab SC	84.4	15.09	Not reported	Not reported	Not reported

Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	60
Daratumumab SC	61

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	80.6	14.62	Not reported	Not reported	Not reported
Daratumumab SC	83.5	15.54	Not reported	Not reported	Not reported

Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	44
Daratumumab SC	40

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	80.2	15.22	Not reported	Not reported	Not reported
Daratumumab SC	86.2	13.51	Not reported	Not reported	Not reported

Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	29
Daratumumab SC	29

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.4	14.84	Not reported	Not reported	Not reported
Daratumumab SC	88.5	13.10	Not reported	Not reported	Not reported

Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	15
Daratumumab SC	20

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	79.0	14.34	Not reported	Not reported	Not reported
Daratumumab SC	90.9	11.26	Not reported	Not reported	Not reported

Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	8
Daratumumab SC	10

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	84.8	14.13	Not reported	Not reported	Not reported
Daratumumab SC	91.4	11.57	Not reported	Not reported	Not reported

Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	2
Daratumumab SC	8

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab IV	92.9	10.10	Not reported	Not reported	Not reported
Daratumumab SC	89.3	13.36	Not reported	Not reported	Not reported

Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	0
Daratumumab SC	4

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab SC	86.6	18.53	Not reported	Not reported	Not reported

Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	0
Daratumumab SC	3

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab SC	84.5	20.93	Not reported	Not reported	Not reported

Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Daratumumab IV	0
Daratumumab SC	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Daratumumab SC	96.4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
15.98
value
70.5
group Id
OG001
spread
14.64
value
76.9
denoms
counts
group Id
OG000
value
227
group Id
OG001
value
230
units
Participants
title
Cycle 1 Day 8
categories
measurements
group Id
OG000
spread
16.72
value
72.1
group Id
OG001
spread
14.95
value
78.8
denoms
counts
group Id
OG000
value
226
group Id
OG001
value
238
units
Participants
title
Cycle 1 Day 15
categories
measurements
group Id
OG000
spread
16.20
value
72.8
group Id
OG001
spread
15.75
value
78.7
denoms
counts
group Id
OG000
value
226
group Id
OG001
value
239
units
Participants
title
Cycle 1 Day 22
categories
measurements
group Id
OG000
spread
16.44
value
74.2
group Id
OG001
spread
16.58
value
79.7
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
238
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
15.57
value
74.8
group Id
OG001
spread
17.24
value
80.1
denoms
counts
group Id
OG000
value
227
group Id
OG001
value
232
units
Participants
title
Cycle 2 Day 8
categories
measurements
group Id
OG000
spread
16.94
value
74.3
group Id
OG001
spread
17.37
value
80.0
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
224
units
Participants
title
Cycle 2 Day 15
categories
measurements
group Id
OG000
spread
16.47
value
75.2
group Id
OG001
spread
18.65
value
79.3
denoms
counts
group Id
OG000
value
221
group Id
OG001
value
214
units
Participants
title
Cycle 2 Day 22
categories
measurements
group Id
OG000
spread
17.39
value
76.0
group Id
OG001
spread
17.78
value
80.4
denoms
counts
group Id
OG000
value
217
group Id
OG001
value
224
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
17.22
value
76.6
group Id
OG001
spread
19.88
value
79.5
denoms
counts
group Id
OG000
value
205
group Id
OG001
value
209
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
17.11
value
77.1
group Id
OG001
spread
18.95
value
79.6
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
188
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
17.79
value
76.1
group Id
OG001
spread
18.34
value
81.9
denoms
counts
group Id
OG000
value
169
group Id
OG001
value
159
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
16.01
value
78.6
group Id
OG001
spread
16.87
value
85.0
denoms
counts
group Id
OG000
value
150
group Id
OG001
value
137
units
Participants
title
Cycle 7 Day 1

denoms

counts
group Id
OG000
value
239
group Id
OG001
value
263
units
Participants

description

Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.

dispersion Type

Standard Deviation

groups

description
Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
OG000
title
Daratumumab IV
description
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
OG001
title
Daratumumab SC

param Type

MEAN

population Description

ITT population included all the randomized participants. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure and 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point.

reporting Status

POSTED

time Frame

Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)

title

Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)

type

SECONDARY

unit Of Measure

Units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice