NCT02963493 · OUTCOME
Functional Status and Well-being: EORTC QLQ-C30
A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-11-22
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
- To be assessed prior to dosing at Cycle 1, 2, 4, 6, 8, and End of Treatment. 23 patients were ongoing for QoL assessments at data cutoff. QoL was added in Protocol Amendment 4 beginning in Oct. 2018.
What was measured
Change from baseline in Patient Reported Outcome questionnaire EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales, 1 Global Health Status scale, 3 symptom scales, and 6 single items. The recall period is 1 week (the past week). The scales are transformed to a 0 (worst) to 100 (best) scale. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact), with a higher score indicating a better HRQoL. If at least 50% of the items from the scale had been answered, the missing items were assumed to have values equal to the average of those items which were present for that respondent.
Analysis population: This outcome measure was prespecified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and Mel + Dex: Patients With TCR Disease.
62 pts in the FAS included after QoL was added in Amd 4, whereof 48 pts in the sub-group of pts with TCR disease.
This outcome measure was not analyzed/reported separately for the sub-group of patients with EMD as there were limited no. of pts with EMD among the QoL patients. No data/results are available to report for patients with EMD.
Groups in this outcome
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.
Melphalan flufenamide (Melflufen)
Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
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 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 62 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 48 |
|---|
Reported measurements
Baseline value
Analysis denominator · Participants
| Group | Source count |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 62 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 48 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 75.5 | 13.2 | Not reported | Not reported | Not reported |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 74.9 | 13.0 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1 Change from baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 51 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 39 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 0.2 | 11.9 | Not reported | Not reported | Not reported |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 74.8 | 13.7 | Not reported | Not reported | Not reported |
|---|
Cycle 4 Day 1 Change from baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 36 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | -2.6 | 12.8 | Not reported | Not reported | Not reported |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 76.9 | 11.9 | Not reported | Not reported | Not reported |
|---|
Cycle 6 Day 1 Change from baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 21 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 14 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | -3.3 | 11.5 | Not reported | Not reported | Not reported |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 73.2 | 12.6 | Not reported | Not reported | Not reported |
|---|
Cycle 8 Day 1 Change from baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 13 |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 9 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | -7.5 | 10.6 | Not reported | Not reported | Not reported |
|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 71.3 | 11.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.2
- value
- 75.5
- group Id
- OG001
- spread
- 13.0
- value
- 74.9
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 48
- units
- Participants
- title
- Baseline value
- categories
- measurements
- group Id
- OG000
- spread
- 11.9
- value
- 0.2
- group Id
- OG001
- spread
- 13.7
- value
- 74.8
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 39
- units
- Participants
- title
- Cycle 2 Day 1 Change from baseline
- categories
- measurements
- group Id
- OG000
- spread
- 12.8
- value
- -2.6
- group Id
- OG001
- spread
- 11.9
- value
- 76.9
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Cycle 4 Day 1 Change from baseline
- categories
- measurements
- group Id
- OG000
- spread
- 11.5
- value
- -3.3
- group Id
- OG001
- spread
- 12.6
- value
- 73.2
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Cycle 6 Day 1 Change from baseline
- categories
- measurements
- group Id
- OG000
- spread
- 10.6
- value
- -7.5
- group Id
- OG001
- spread
- 11.3
- value
- 71.3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 8 Day 1 Change from baseline
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- Change from baseline in Patient Reported Outcome questionnaire EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales, 1 Global Health Status scale, 3 symptom scales, and 6 single items. The recall period is 1 week (the past week). The scales are transformed to a 0 (worst) to 100 (best) scale. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact), with a higher score indicating a better HRQoL. If at least 50% of the items from the scale had been answered, the missing items were assumed to have values equal to the average of those items which were present for that respondent.
- dispersion Type
- Standard Deviation
- groups
- description
- Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.
Melphalan flufenamide (Melflufen)
Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
- id
- OG000
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
- description
- Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
- id
- OG001
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
- param Type
- MEAN
- population Description
- This outcome measure was prespecified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and Mel + Dex: Patients With TCR Disease.
62 pts in the FAS included after QoL was added in Amd 4, whereof 48 pts in the sub-group of pts with TCR disease.
This outcome measure was not analyzed/reported separately for the sub-group of patients with EMD as there were limited no. of pts with EMD among the QoL patients. No data/results are available to report for patients with EMD.
- reporting Status
- POSTED
- time Frame
- To be assessed prior to dosing at Cycle 1, 2, 4, 6, 8, and End of Treatment. 23 patients were ongoing for QoL assessments at data cutoff. QoL was added in Protocol Amendment 4 beginning in Oct. 2018.
- title
- Functional Status and Well-being: EORTC QLQ-C30
- type
- SECONDARY
- unit Of Measure
- units on a scale
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