Trial Outcomes & Findings for 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 (NCT NCT03384654)
NCT ID: NCT03384654
Last Updated: 2025-05-25
Results Overview
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (\>)100\*10\^9 cells/liter (L) and absolute neutrophil count (ANC) \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arm only.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)
Results posted on
2025-05-25
Participant Flow
After enrollment of 47 participants, one participant in Cohort 1: B-cell acute lymphoblastic leukemia (ALL) (1-17 Years) was withdrawn prior to receiving treatment, and thus only 46 participants were treated in the study.
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
24
|
5
|
10
|
|
Overall Study
COMPLETED
|
7
|
24
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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)
n=24 Participants
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)
n=5 Participants
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)
n=10 Participants
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).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.1 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
9.8 years
STANDARD_DEVIATION 4.17 • n=7 Participants
|
22.2 years
STANDARD_DEVIATION 2.77 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 5.68 • n=4 Participants
|
11.7 years
STANDARD_DEVIATION 6.03 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
BELGIUM
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
GERMANY
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
ISRAEL
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
ITALY
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
NETHERLANDS
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
SPAIN
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED STATES
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)Population: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (\>)100\*10\^9 cells/liter (L) and absolute neutrophil count (ANC) \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arm only.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (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).
|
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).
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
|
0 Percentage of participants
Here, "NA" indicates that lower and upper limit of 90% confidential interval (CI) was not estimable because no participants had the event.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of Cycle 1 (that is, up to 28 days)Population: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=24 Participants
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 (18-30 Years)
n=5 Participants
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)
n=10 Participants
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).
|
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).
|
|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
|
41.7 Percentage of participants
Interval 24.6 to 60.3
|
60.0 Percentage of participants
Interval 18.9 to 92.4
|
30.0 Percentage of participants
Interval 8.7 to 60.7
|
—
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets \>100\*10\^9 cells/L and ANC \>1.0\*10\^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of \>=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
14.3 Percentage of participants
Interval 0.7 to 52.1
|
83.3 Percentage of participants
Interval 65.8 to 94.1
|
80.0 Percentage of participants
Interval 34.3 to 99.0
|
50.0 Percentage of participants
Interval 22.2 to 77.8
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is \[ie\], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Event-free Survival (EFS)
|
1.1 Months
Interval 0.9 to 2.1
|
8.9 Months
Interval 5.3 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
10.3 Months
Interval 2.6 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
2.9 Months
Interval 1.3 to 4.9
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The response evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and had at least 1 adequate post-baseline disease assessment. Here, 'N' (number of participants analysed) signifies all treated participants who achieved a complete response.
RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or \>5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
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 (18-30 Years)
n=12 Participants
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)
n=3 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=4 Participants
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).
|
|---|---|---|---|---|
|
Relapse-free Survival (RFS)
|
—
|
19.4 Months
Interval 5.3 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
9.4 Months
Interval 3.6 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
NA Months
Interval 1.8 to
Here, "NA" indicates that median and upper limit of 90% CI was not evaluable due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
3.2 Months
Interval 1.0 to 3.6
|
10.9 Months
Interval 6.7 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
12.0 Months
Interval 4.5 to
Here, "NA" indicates that upper limit of 90% CI was not evaluable due to less number of participants with events.
|
4.2 Months
Interval 1.7 to 5.6
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (\<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Minimal Residual Disease (MRD) Negative Rate
|
0 Percentage of participants
Interval 0.0 to 0.0
|
45.8 Percentage of participants
Interval 28.2 to 64.2
|
20.0 Percentage of participants
Interval 1.0 to 65.7
|
50.0 Percentage of participants
Interval 22.2 to 77.8
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
|
14.3 Percentage of participants
Interval 0.7 to 52.1
|
75.0 Percentage of participants
Interval 56.5 to 88.5
|
60.0 Percentage of participants
Interval 18.9 to 92.4
|
30.0 Percentage of participants
Interval 8.7 to 60.7
|
SECONDARY outcome
Timeframe: Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2Population: The serum pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion blood sample for serum daratumumab concentrations.
Cmax was defined as maximum observed serum concentration of daratumumab.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Daratumumab
|
494 Micrograms per milliliter (mcg/mL)
Standard Deviation 184
|
763 Micrograms per milliliter (mcg/mL)
Standard Deviation 185
|
501 Micrograms per milliliter (mcg/mL)
Standard Deviation 347
|
758 Micrograms per milliliter (mcg/mL)
Standard Deviation 157
|
SECONDARY outcome
Timeframe: Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2Population: The serum PK evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion blood sample for serum daratumumab concentrations.
Cmin was defined as minimum observed serum concentration of daratumumab.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 Participants
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 (18-30 Years)
n=24 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Minimum Observed Serum Concentration (Cmin) of Daratumumab
|
172 mcg/mL
Standard Deviation 115
|
369 mcg/mL
Standard Deviation 105
|
172 mcg/mL
Standard Deviation 177
|
365 mcg/mL
Standard Deviation 204
|
SECONDARY outcome
Timeframe: Up to 4 years 4 monthsPopulation: The immunogenicity evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and had at least 1 post-infusion sample for detection of anti-daratumumab antibodies.
Number of participants with anti-daratumumab antibodies was reported.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=5 Participants
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 (18-30 Years)
n=22 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=9 Participants
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).
|
|---|---|---|---|---|
|
Number of Participants With Anti-daratumumab Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 15Population: 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.
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.
Outcome measures
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=3 Participants
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 (18-30 Years)
n=21 Participants
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)
n=5 Participants
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).
|
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
n=10 Participants
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).
|
|---|---|---|---|---|
|
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Cycle 1 Day 1 predose
|
NA mcg/mL
Standard Deviation NA
Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
|
NA mcg/mL
Standard Deviation NA
Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
|
NA mcg/mL
Standard Deviation NA
Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
|
NA mcg/mL
Standard Deviation NA
Here, "NA" indicates that mean and standard deviation could not calculated due to the lower limit of quantification (LLOQ) limit (0.015 mcg/mL).
|
|
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Cycle 1 Day 15 predose
|
—
|
0.907 mcg/mL
Standard Deviation 1.96
|
0.319 mcg/mL
Standard Deviation 0.203
|
0.456 mcg/mL
Standard Deviation 0.280
|
|
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Cycle 2 Day 1 predose
|
0.573 mcg/mL
Standard Deviation 0.545
|
—
|
—
|
—
|
|
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Cycle 2 Day 2 predose
|
—
|
0.915 mcg/mL
Standard Deviation 0.916
|
0.296 mcg/mL
Standard Deviation 0.191
|
1.23 mcg/mL
Standard Deviation 0.728
|
|
Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
Cycle 2 Day 15 predose
|
—
|
0.934 mcg/mL
Standard Deviation 0.549
|
0.163 mcg/mL
|
1.06 mcg/mL
Standard Deviation 0.282
|
Adverse Events
Cohort 1: B-cell ALL (1-17 Years)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 7 deaths
Cohort 2: T-Cell ALL (1-17 Years)
Serious events: 16 serious events
Other events: 24 other events
Deaths: 14 deaths
Cohort 2: T-Cell ALL (18-30 Years)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 participants at risk
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)
n=24 participants at risk
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)
n=5 participants at risk
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)
n=10 participants at risk
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).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
42.9%
3/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
25.0%
6/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Death
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
29.2%
7/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Campylobacter Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Enterobacter Bacteraemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Blood Lactic Acid Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Pseudomonas Test Positive
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Staphylococcus Test Positive
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Weight Decreased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Peripheral Nerve Palsy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Inflammation
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
Other adverse events
| Measure |
Cohort 1: B-cell ALL (1-17 Years)
n=7 participants at risk
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)
n=24 participants at risk
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)
n=5 participants at risk
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)
n=10 participants at risk
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).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
4/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
66.7%
16/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
100.0%
10/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
29.2%
7/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Hypocoagulable State
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Leukopenia
|
42.9%
3/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
37.5%
9/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.8%
5/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
62.5%
15/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
6/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
75.0%
18/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
90.0%
9/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Cardiac disorders
Sinus Tachycardia
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Ear and labyrinth disorders
Ear Pain
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Eye disorders
Eye Oedema
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
12/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Anal Fissure
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Anal Inflammation
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
25.0%
6/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
80.0%
4/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
29.2%
7/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Lip Dry
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
45.8%
11/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
41.7%
10/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
70.0%
7/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Tongue Coated
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
58.3%
14/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Asthenia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Catheter Site Haematoma
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Chills
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Face Oedema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Fatigue
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Generalised Oedema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Localised Oedema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
54.2%
13/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
70.0%
7/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
General disorders
Vascular Device Occlusion
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Hepatobiliary disorders
Hepatic Cytolysis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
29.2%
7/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
80.0%
4/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Kidney Infection
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Splenic Infection Fungal
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Alanine Aminotransferase Increased
|
42.9%
3/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
37.5%
9/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Ammonia Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Antithrombin Iii Decreased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Aspartate Aminotransferase Increased
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
80.0%
4/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Interleukin Level Increased
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Lipase Increased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Urine Output Decreased
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Weight Decreased
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Investigations
Weight Increased
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.8%
5/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
12/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
33.3%
8/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
25.0%
6/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
80.0%
4/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Depressed Level of Consciousness
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
12.5%
3/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Facial Paralysis
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
45.8%
11/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Product Issues
Device Occlusion
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Renal and urinary disorders
Renal Tubular Disorder
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Renal and urinary disorders
Urinary Retention
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Cough
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
3/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
29.2%
7/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
50.0%
5/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
30.0%
3/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
25.0%
6/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
60.0%
3/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Enanthema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Acne
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
2/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Skin Striae
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
16.7%
4/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Social circumstances
Menopause
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
4.2%
1/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
10.0%
1/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.8%
5/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
40.0%
4/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
8.3%
2/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
2/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Superficial Vein Thrombosis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/7 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/24 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
20.0%
1/5 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
0.00%
0/10 • From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER