NCT02761187 · OUTCOME

Reasons for Treatment Modifications

An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants · Source last updated 2025-02-24

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: Baseline up to 5 years

Analysis population: All Enrolled Population included all participants who signed informed consent. Participants received more than one LOT and are counted in more than one LOT. The data is reported as per the known line of therapies. Participants were counted multiple times in different categories. The overall number of participants analyzed is the number of participants available for analyses.

Groups in this outcome

1st Line of Therapy

The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

2nd Line of Therapy

The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

3rd Line of Therapy

The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

4th Line of Therapy

The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

>4th Line of Therapy

The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

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
1st Line of Therapy	2260
2nd Line of Therapy	1878
3rd Line of Therapy	1416
4th Line of Therapy	700
>4th Line of Therapy	500

Reported measurements

Adverse Event Related to Drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	920	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	676	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	459	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	240	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	187	Not reported	Not reported	Not reported	Not reported

Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	425	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	333	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	248	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	110	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	81	Not reported	Not reported	Not reported	Not reported

Planned Change

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	386	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	274	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	205	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	99	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	62	Not reported	Not reported	Not reported	Not reported

Adverse Event Not Related to MM Therapy Drug

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	234	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	243	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	179	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	91	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	62	Not reported	Not reported	Not reported	Not reported

Current Dose Tolerated, Dose Increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	110	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	107	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	105	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	47	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	30	Not reported	Not reported	Not reported	Not reported

Dose Delay Due to Toxicity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	63	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	91	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	65	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	32	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	22	Not reported	Not reported	Not reported	Not reported

Patient/Family Preference

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	53	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	58	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	39	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	19	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	16	Not reported	Not reported	Not reported	Not reported

Treatment Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	25	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	36	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	33	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	17	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	13	Not reported	Not reported	Not reported	Not reported

Lack of Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	16	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	23	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	27	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	11	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	13	Not reported	Not reported	Not reported	Not reported

COVID-19 Restrictions

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	13	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	21	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	22	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	11	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	8	Not reported	Not reported	Not reported	Not reported

Relapse - Biochemical Progression

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	9	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	17	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	19	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	11	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	7	Not reported	Not reported	Not reported	Not reported

COVID-19 Diagnosis (Confirmed Positive)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	5	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	11	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	7	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	8	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	3	Not reported	Not reported	Not reported	Not reported

Relapse - Symptomatic/Clinical Progression

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	5	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	10	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	3	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	2	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	3	Not reported	Not reported	Not reported	Not reported

COVID-19 Diagnosis (Suspected Positive)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	3	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	0	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	1	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	0	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	0	Not reported	Not reported	Not reported	Not reported

Missing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
1st Line of Therapy	6	Not reported	Not reported	Not reported	Not reported
2nd Line of Therapy	13	Not reported	Not reported	Not reported	Not reported
3rd Line of Therapy	4	Not reported	Not reported	Not reported	Not reported
4th Line of Therapy	2	Not reported	Not reported	Not reported	Not reported
>4th Line of Therapy	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
920
group Id
OG001
value
676
group Id
OG002
value
459
group Id
OG003
value
240
group Id
OG004
value
187
title
Adverse Event Related to Drug
categories
measurements
group Id
OG000
value
425
group Id
OG001
value
333
group Id
OG002
value
248
group Id
OG003
value
110
group Id
OG004
value
81
title
Other
categories
measurements
group Id
OG000
value
386
group Id
OG001
value
274
group Id
OG002
value
205
group Id
OG003
value
99
group Id
OG004
value
62
title
Planned Change
categories
measurements
group Id
OG000
value
234
group Id
OG001
value
243
group Id
OG002
value
179
group Id
OG003
value
91
group Id
OG004
value
62
title
Adverse Event Not Related to MM Therapy Drug
categories
measurements
group Id
OG000
value
110
group Id
OG001
value
107
group Id
OG002
value
105
group Id
OG003
value
47
group Id
OG004
value
30
title
Current Dose Tolerated, Dose Increased
categories
measurements
group Id
OG000
value
63
group Id
OG001
value
91
group Id
OG002
value
65
group Id
OG003
value
32
group Id
OG004
value
22
title
Dose Delay Due to Toxicity
categories
measurements
group Id
OG000
value
53
group Id
OG001
value
58
group Id
OG002
value
39
group Id
OG003
value
19
group Id
OG004
value
16
title
Patient/Family Preference
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
36
group Id
OG002
value
33
group Id
OG003
value
17
group Id
OG004
value
13
title
Treatment Fatigue
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
23
group Id
OG002
value
27
group Id
OG003
value
11
group Id
OG004
value
13
title
Lack of Response
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
21
group Id
OG002
value
22
group Id
OG003
value
11
group Id
OG004
value
8
title
COVID-19 Restrictions
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
17
group Id
OG002
value
19
group Id
OG003
value
11
group Id
OG004
value
7
title
Relapse - Biochemical Progression
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
7
group Id
OG003
value
8
group Id
OG004
value
3
title
COVID-19 Diagnosis (Confirmed Positive)

denoms

counts
group Id
OG000
value
2260
group Id
OG001
value
1878
group Id
OG002
value
1416
group Id
OG003
value
700
group Id
OG004
value
500
units
Participants

groups

description
The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
id
OG000
title
1st Line of Therapy
description
The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
id
OG001
title
2nd Line of Therapy
description
The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
id
OG002
title
3rd Line of Therapy
description
The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
id
OG003
title
4th Line of Therapy
description
The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
id
OG004
title
>4th Line of Therapy

param Type

COUNT_OF_PARTICIPANTS

population Description

All Enrolled Population included all participants who signed informed consent. Participants received more than one LOT and are counted in more than one LOT. The data is reported as per the known line of therapies. Participants were counted multiple times in different categories. The overall number of participants analyzed is the number of participants available for analyses.

reporting Status

POSTED

time Frame

Baseline up to 5 years

title

Reasons for Treatment Modifications

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice