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Also known as Daratumumab Subcutaneous (SC) Administration
Daratumumab Administration · 1 trial · 1 indication
Ctrough: the concentration prior to study drug administration.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 | EXPERIMENTAL | Participants will receive 1200 mg (daratumumab 1200 milligram (mg) with Recombinant Human Hyaluronidase \[rHuPH20\] 30,000 U) via mixing immediately before Subcutaneous (SC) infusion once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression. |
| Part 1: Cohort 2 | EXPERIMENTAL | Participants will receive 1800 mg (daratumumab 1800 milligram (mg) with Recombinant Human Hyaluronidase \[rHuPH20\] 45,000 U) via mixing immediately before SC infusion once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression. |
| Part 1: Cohort 3 | EXPERIMENTAL | Participants will receive mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery at a dose which will be decided by Study Evaluation Team (SET) once weekly by SC infusion in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression. Also up to three additional optional cohorts (Cohorts 3b, 3c, and 3d) may be enrolled to repeat a dose level of daratumumab. |
| Part 2: Cohort 4 | EXPERIMENTAL | Participants will receive 1800 mg co-formulated daratumumab and rHuPH20 preparation initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles. The dose level and schedule for any additional cohorts would be selected based on the daratumumab pharmacokinetic profile and safety profile (reviewed by the SET) that will be observed in Cohort 4. |
| Part 3: Dara-CF 1800 mg | EXPERIMENTAL | Participants will receive co-formulated daratumumab 1800 mg and rHuPH20 preparation (Dara-CF) initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles. |
| Name | Type | Description |
|---|---|---|
| Daratumumab Subcutaneous (SC) Administration | DRUG | Participants will receive Daratumumab mixed with rHuPH20 in part 1 and co-formulated with rHuPH20 in part 2 and part 3 administered via SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles. |
| Recombinant Human Hyaluronidase [rHuPH20]) SC Administration | DRUG | Participants will receive Recombinant Human Hyaluronidase \[rHuPH20\]) mixed with Daratumumab in part 1 and co-formulated with Daratumumab in part 2 and part 3 administered as SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles. |
Inclusion Criteria: * Participants proven to have multiple myeloma (MM) diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria * Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] le...
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Daratumumab Administration is used in multiple myeloma, a cancer of plasma cells in the bone marrow. The clinical program described here studied daratumumab given with recombinant human hyaluronidase in participants with relapsed or refractory multiple myeloma. It is an oncology therapy developed by Johnson & Johnson.
Daratumumab Administration targets CD38, a protein expressed on the surface of multiple myeloma cells. Daratumumab is a monoclonal antibody that binds CD38, and the subcutaneous formulation adds recombinant human hyaluronidase to allow administration under the skin. The target class is an inhibitor of CD38.
Daratumumab Administration is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the daratumumab subcutaneous program studied in relapsed or refractory multiple myeloma.
Daratumumab Administration is in Phase 1 clinical development for multiple myeloma. The single trial in this program is listed as completed, and the drug remains investigational rather than approved for the subcutaneous administration studied here.
Daratumumab Administration was studied in the Phase 1 trial NCT02519452, titled A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma. It enrolled 120 participants across the United States, Denmark, France, the Netherlands, Spain, and Sweden, and is completed.
Yes, Daratumumab Administration is also known as Daratumumab Subcutaneous (SC) Administration. Both names refer to the same daratumumab product given under the skin with recombinant human hyaluronidase, studied in relapsed or refractory multiple myeloma.