NCT02990338 · OUTCOME
Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- microgram per milliliter (mcg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1
What was measured
CEOI was defined as the plasma concentration at end of infusion.
Analysis population: Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure (OM) was not planned to be collected and analyzed for Pd arm.
Groups in this outcome
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
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 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 149 |
|---|
Reported measurements
End of infusion: C1D1
Analysis denominator · Participants
| Group | Source count |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 141 |
|---|
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 163.05 | 34.528 | Not reported | Not reported | Not reported |
|---|
End of infusion: C1D15
Analysis denominator · Participants
| Group | Source count |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 120 |
|---|
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 269.20 | 32.622 | Not reported | Not reported | Not reported |
|---|
End of infusion: C2D1
Analysis denominator · Participants
| Group | Source count |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 134 |
|---|
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 299.85 | 35.921 | Not reported | Not reported | Not reported |
|---|
End of infusion: C4D1
Analysis denominator · Participants
| Group | Source count |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 117 |
|---|
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 279.31 | 47.555 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 34.528
- value
- 163.05
- title
- End of infusion: C1D1
- categories
- measurements
- group Id
- OG000
- spread
- 32.622
- value
- 269.20
- title
- End of infusion: C1D15
- categories
- measurements
- group Id
- OG000
- spread
- 35.921
- value
- 299.85
- title
- End of infusion: C2D1
- categories
- measurements
- group Id
- OG000
- spread
- 47.555
- value
- 279.31
- title
- End of infusion: C4D1
- description
- CEOI was defined as the plasma concentration at end of infusion.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
- id
- OG000
- title
- IPd (Isatuximab + Pomalidomide + Dexamethasone)
- param Type
- GEOMETRIC_MEAN
- population Description
- Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure (OM) was not planned to be collected and analyzed for Pd arm.
- reporting Status
- POSTED
- time Frame
- End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1
- title
- Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)
- type
- SECONDARY
- unit Of Measure
- microgram per milliliter (mcg/mL)
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