NCT03871829 · OUTCOME
Serum Concentrations of Daratumumab
Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab · Source last updated 2025-03-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- microgram per milliliters (mcg/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)
What was measured
Serum concentrations of daratumumab were assessed. This outcome measure was planned to be analyzed for specified arm only.
Analysis population: Pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of daratumumab subcutaneous (dara-SC) and had at least 1 post-dose PK sample. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.
Groups in this outcome
Arm B: Dara-SC in Combination With Kd (DKd)
Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
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 |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 22 |
|---|
Reported measurements
Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 6 |
|---|
Values in microgram per milliliters (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 39.1 | 44.1 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 22 |
|---|
Values in microgram per milliliters (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 849 | 329 | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 19 |
|---|
Values in microgram per milliliters (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 715 | 381 | Not reported | Not reported | Not reported |
|---|
Post-treatment Week 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 4 |
|---|
Values in microgram per milliliters (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 85.5 | 131 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 44.1
- value
- 39.1
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 329
- value
- 849
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 381
- value
- 715
- title
- Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 131
- value
- 85.5
- title
- Post-treatment Week 8
- description
- Serum concentrations of daratumumab were assessed. This outcome measure was planned to be analyzed for specified arm only.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
- id
- OG000
- title
- Arm B: Dara-SC in Combination With Kd (DKd)
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of daratumumab subcutaneous (dara-SC) and had at least 1 post-dose PK sample. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)
- title
- Serum Concentrations of Daratumumab
- type
- SECONDARY
- unit Of Measure
- microgram per milliliters (mcg/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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