NCT03384654 · OUTCOME
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2025-05-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
What was measured
Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
Analysis population: The CSF PK evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion CSF sample for daratumumab concentrations. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represent number of participants evaluable for specified timepoints.
Groups in this outcome
Cohort 1: B-cell ALL (1-17 Years)
Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).
Cohort 2: T-Cell ALL (1-17 Years)
Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
Cohort 2: T-Cell ALL (18-30 Years)
Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
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 |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 3 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 21 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 5 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 10 |
|---|
Reported measurements
Cycle 1 Day 1 predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 3 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 18 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 3 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 10 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | NA | NA | Not reported | Not reported | Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL). |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | NA | NA | Not reported | Not reported | Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL). |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | NA | NA | Not reported | Not reported | Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL). |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | NA | NA | Not reported | Not reported | Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL). |
|---|
Cycle 1 Day 15 predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 21 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 5 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 10 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 0.907 | 1.96 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 0.319 | 0.203 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 0.456 | 0.280 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1 predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 3 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 0 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 0 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 0 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0.573 | 0.545 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 2 predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 14 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 3 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 5 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 0.915 | 0.916 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 0.296 | 0.191 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 1.23 | 0.728 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 15 predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: B-cell ALL (1-17 Years) | 0 |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 16 |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 1 |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 5 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 2: T-Cell ALL (1-17 Years) | 0.934 | 0.549 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell ALL (18-30 Years) | 0.163 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | 1.06 | 0.282 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
- group Id
- OG003
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- units
- Participants
- title
- Cycle 1 Day 1 predose
- categories
- measurements
- group Id
- OG001
- spread
- 1.96
- value
- 0.907
- group Id
- OG002
- spread
- 0.203
- value
- 0.319
- group Id
- OG003
- spread
- 0.280
- value
- 0.456
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 10
- units
- Participants
- title
- Cycle 1 Day 15 predose
- categories
- measurements
- group Id
- OG000
- spread
- 0.545
- value
- 0.573
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 2 Day 1 predose
- categories
- measurements
- group Id
- OG001
- spread
- 0.916
- value
- 0.915
- group Id
- OG002
- spread
- 0.191
- value
- 0.296
- group Id
- OG003
- spread
- 0.728
- value
- 1.23
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- units
- Participants
- title
- Cycle 2 Day 2 predose
- categories
- measurements
- group Id
- OG001
- spread
- 0.549
- value
- 0.934
- group Id
- OG002
- value
- 0.163
- group Id
- OG003
- spread
- 0.282
- value
- 1.06
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- units
- Participants
- title
- Cycle 2 Day 15 predose
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).
- id
- OG000
- title
- Cohort 1: B-cell ALL (1-17 Years)
- description
- Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
- id
- OG001
- title
- Cohort 2: T-Cell ALL (1-17 Years)
- description
- Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
- id
- OG002
- title
- Cohort 2: T-Cell ALL (18-30 Years)
- description
- Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
- id
- OG003
- title
- Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
- param Type
- MEAN
- population Description
- The CSF PK evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion CSF sample for daratumumab concentrations. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represent number of participants evaluable for specified timepoints.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15
- title
- Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
- type
- SECONDARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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