NCT05405166 · OUTCOME
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- number of nights
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Cycle 1 Day 1)
What was measured
Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of nights in the past 6 month a participant stayed in hospital for any health issue including MM or due to MM and stayed in intensive care unit (ICU) for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Analysis population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.
Groups in this outcome
Isa-IV + Pd
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
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 |
|---|
| Isa-IV + Pd | 50 |
|---|
| Isa-SC + Pd | 62 |
|---|
Reported measurements
Stayed in hospital for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 50 |
|---|
| Isa-SC + Pd | 62 |
|---|
Values in number of nights · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 7.2 | 12.3 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 5.2 | 9.0 | Not reported | Not reported | Not reported |
|---|
Stayed in hospital due to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 38 |
|---|
| Isa-SC + Pd | 37 |
|---|
Values in number of nights · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 10.3 | 20.2 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 6.5 | 10.3 | Not reported | Not reported | Not reported |
|---|
Stayed in ICU for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 3 |
|---|
| Isa-SC + Pd | 6 |
|---|
Values in number of nights · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 5.0 | 2.6 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 1.3 | 0.5 | Not reported | Not reported | Not reported |
|---|
Stayed in ICU due to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 0 |
|---|
| Isa-SC + Pd | 3 |
|---|
Values in number of nights · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-SC + Pd | 3.0 | 2.0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.3
- value
- 7.2
- group Id
- OG001
- spread
- 9.0
- value
- 5.2
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Stayed in hospital for any health issue including MM
- categories
- measurements
- group Id
- OG000
- spread
- 20.2
- value
- 10.3
- group Id
- OG001
- spread
- 10.3
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Stayed in hospital due to MM
- categories
- measurements
- group Id
- OG000
- spread
- 2.6
- value
- 5.0
- group Id
- OG001
- spread
- 0.5
- value
- 1.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Stayed in ICU for any health issue including MM
- categories
- measurements
- group Id
- OG001
- spread
- 2.0
- value
- 3.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Stayed in ICU due to MM
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of nights in the past 6 month a participant stayed in hospital for any health issue including MM or due to MM and stayed in intensive care unit (ICU) for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG000
- title
- Isa-IV + Pd
- description
- Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
- id
- OG001
- title
- Isa-SC + Pd
- param Type
- MEAN
- population Description
- The ITT population included all randomized population. Only those participants with responses at Baseline are presented.
- reporting Status
- POSTED
- time Frame
- Baseline (Cycle 1 Day 1)
- title
- HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
- type
- SECONDARY
- unit Of Measure
- number of nights
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Preserved source evidence · Not medical advice
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