NCT02761187 · OUTCOME
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
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
- At Baseline
What was measured
FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\].
Analysis population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
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 | 1790 |
|---|
| 2nd Line of Therapy | 686 |
|---|
| 3rd Line of Therapy | 458 |
|---|
| 4th Line of Therapy | 249 |
|---|
| >4th Line of Therapy | 80 |
|---|
Reported measurements
Del(17p)/p53
Not Reported/Performed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 208 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 20 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 126 | 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 | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 950 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 147 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 55 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Done - Inferred
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 399 | 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 | 2 | 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 | 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 | 107 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 479 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 382 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 214 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 68 | Not reported | Not reported | Not reported | Not reported |
|---|
t(4,14)
Not Reported/Performed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 208 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 20 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 116 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 24 | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 957 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 144 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 63 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Done - Inferred
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 401 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 2 | 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 | 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 | 108 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 480 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 382 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 213 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 68 | Not reported | Not reported | Not reported | Not reported |
|---|
t(14,16)
Not Reported/Performed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 208 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 20 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 1007 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 157 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Done - Inferred
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 1st Line of Therapy | 416 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 2 | 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 | 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 | 109 | Not reported | Not reported | Not reported | Not reported |
|---|
| 2nd Line of Therapy | 484 | Not reported | Not reported | Not reported | Not reported |
|---|
| 3rd Line of Therapy | 382 | Not reported | Not reported | Not reported | Not reported |
|---|
| 4th Line of Therapy | 213 | Not reported | Not reported | Not reported | Not reported |
|---|
| >4th Line of Therapy | 68 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- title
- Not Reported/Performed
- measurements
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 950
- group Id
- OG001
- value
- 147
- group Id
- OG002
- value
- 55
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 12
- title
- No
- measurements
- group Id
- OG000
- value
- 399
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- title
- Not Done - Inferred
- measurements
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 479
- group Id
- OG002
- value
- 382
- group Id
- OG003
- value
- 214
- group Id
- OG004
- value
- 68
- title
- Missing
- title
- Del(17p)/p53
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- title
- Not Reported/Performed
- measurements
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- title
- Yes
- measurements
- group Id
- OG000
- value
- 957
- group Id
- OG001
- value
- 144
- group Id
- OG002
- value
- 63
- group Id
- OG003
- value
- 25
- group Id
- OG004
- value
- 9
- title
- No
- measurements
- group Id
- OG000
- value
- 401
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- title
- Not Done - Inferred
- measurements
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 480
- group Id
- OG002
- value
- 382
- group Id
- OG003
- value
- 213
- group Id
- OG004
- value
- 68
- title
- Missing
- title
- t(4,14)
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- title
- Not Reported/Performed
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 1007
- group Id
- OG001
- value
- 157
- group Id
- OG002
- value
- 67
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 12
- title
- No
- measurements
- group Id
- OG000
- value
- 416
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- title
- Not Done - Inferred
- measurements
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 484
- group Id
- OG002
- value
- 382
- group Id
- OG003
- value
- 213
- group Id
- OG004
- value
- 68
- title
- Missing
- title
- t(14,16)
- denoms
- counts
- group Id
- OG000
- value
- 1790
- group Id
- OG001
- value
- 686
- group Id
- OG002
- value
- 458
- group Id
- OG003
- value
- 249
- group Id
- OG004
- value
- 80
- units
- Participants
- description
- FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\].
- 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 the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
- reporting Status
- POSTED
- time Frame
- At Baseline
- title
- Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle