NCT05405166 · OUTCOME
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
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 times consulted a HCP
- 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 times in the past 6 months a participant consulted (had seen or talked to) following healthcare professionals: general doctor or primary care clinician (PCC) who treats a variety of illnesses for any health issue including MM or related to MM, physical or occupational therapist for any health issue including MM or related to MM, mental health professional (e.g. psychiatrist, psychologist, psychiatric nurse) for any health issue including MM or related to MM, medical doctor or clinician who specializes in particular medical disease or issue (specialist) for any health issue including MM or related 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 | 113 |
|---|
| Isa-SC + Pd | 110 |
|---|
Reported measurements
General doctor or PCC for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 113 |
|---|
| Isa-SC + Pd | 110 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 4.5 | 3.9 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 4.9 | 5.4 | Not reported | Not reported | Not reported |
|---|
General doctor or PCC for health issue related to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 101 |
|---|
| Isa-SC + Pd | 89 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 4.5 | 3.9 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 5.3 | 7.6 | Not reported | Not reported | Not reported |
|---|
Physical or occupational therapist for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 25 |
|---|
| Isa-SC + Pd | 35 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 6.3 | 5.3 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 6.7 | 9.7 | Not reported | Not reported | Not reported |
|---|
Physical or occupational therapist for health issue related to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 21 |
|---|
| Isa-SC + Pd | 26 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 6.2 | 5.4 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 5.0 | 6.4 | Not reported | Not reported | Not reported |
|---|
Mental health professional for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 18 |
|---|
| Isa-SC + Pd | 17 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 3.2 | 3.0 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 5.2 | 7.4 | Not reported | Not reported | Not reported |
|---|
Mental health professional for health issue related to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 16 |
|---|
| Isa-SC + Pd | 13 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 3.3 | 2.4 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 4.4 | 7.8 | Not reported | Not reported | Not reported |
|---|
Medical doctor or clinician (specialist) for any health issue including MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 76 |
|---|
| Isa-SC + Pd | 80 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 4.2 | 3.1 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 4.4 | 3.3 | Not reported | Not reported | Not reported |
|---|
Medical doctor or clinician (specialist) for health issue related to MM
Analysis denominator · Participants
| Group | Source count |
|---|
| Isa-IV + Pd | 77 |
|---|
| Isa-SC + Pd | 79 |
|---|
Values in number of times consulted a HCP · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Isa-IV + Pd | 4.5 | 3.0 | Not reported | Not reported | Not reported |
|---|
| Isa-SC + Pd | 4.2 | 2.4 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.9
- value
- 4.5
- group Id
- OG001
- spread
- 5.4
- value
- 4.9
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 110
- units
- Participants
- title
- General doctor or PCC for any health issue including MM
- categories
- measurements
- group Id
- OG000
- spread
- 3.9
- value
- 4.5
- group Id
- OG001
- spread
- 7.6
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 89
- units
- Participants
- title
- General doctor or PCC for health issue related to MM
- categories
- measurements
- group Id
- OG000
- spread
- 5.3
- value
- 6.3
- group Id
- OG001
- spread
- 9.7
- value
- 6.7
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 35
- units
- Participants
- title
- Physical or occupational therapist for any health issue including MM
- categories
- measurements
- group Id
- OG000
- spread
- 5.4
- value
- 6.2
- group Id
- OG001
- spread
- 6.4
- value
- 5.0
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- Physical or occupational therapist for health issue related to MM
- categories
- measurements
- group Id
- OG000
- spread
- 3.0
- value
- 3.2
- group Id
- OG001
- spread
- 7.4
- value
- 5.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Mental health professional for any health issue including MM
- categories
- measurements
- group Id
- OG000
- spread
- 2.4
- value
- 3.3
- group Id
- OG001
- spread
- 7.8
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Mental health professional for health issue related to MM
- categories
- measurements
- group Id
- OG000
- spread
- 3.1
- value
- 4.2
- group Id
- OG001
- spread
- 3.3
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Medical doctor or clinician (specialist) for any health issue including MM
- categories
- measurements
- group Id
- OG000
- spread
- 3.0
- value
- 4.5
- group Id
- OG001
- spread
- 2.4
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 79
- units
- Participants
- title
- Medical doctor or clinician (specialist) for health issue related to MM
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant consulted (had seen or talked to) following healthcare professionals: general doctor or primary care clinician (PCC) who treats a variety of illnesses for any health issue including MM or related to MM, physical or occupational therapist for any health issue including MM or related to MM, mental health professional (e.g. psychiatrist, psychologist, psychiatric nurse) for any health issue including MM or related to MM, medical doctor or clinician who specializes in particular medical disease or issue (specialist) for any health issue including MM or related 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 Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
- type
- SECONDARY
- unit Of Measure
- number of times consulted a HCP
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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