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JNJ-54767414 · 1 trial · 1 indication
An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
| Arm | Type | Description |
|---|---|---|
| JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone | EXPERIMENTAL | Participants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles. |
| Name | Type | Description |
|---|---|---|
| JNJ-54767414 (Daratumumab) | DRUG | JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. |
| Bortezomib | DRUG | Bortezomib will be administered at a dose of 1.3 mg/m\^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered. |
| Dexamethasone | DRUG | Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication. |
Inclusion Criteria: * Participants proven to have symptomatic (having symptoms) multiple myeloma (MM) according the International Myeloma Working Group (IMWG) diagnostic criteria * Participant must have documented MM as defined by following criteria: Monoclonal plasma cells in the bone marrow 10 pe...
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JNJ-54767414 is an investigational small molecule being studied for the treatment of multiple myeloma. It is being evaluated in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma. The drug is currently in Phase 1 clinical development.
JNJ-54767414 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is in Phase 1 clinical development for the treatment of multiple myeloma.
JNJ-54767414 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug in combination with bortezomib and dexamethasone has been completed.
JNJ-54767414 has one completed clinical trial, identified as NCT02497378. This Phase 1 study evaluated the drug in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma. The trial enrolled 8 participants and was completed.
JNJ-54767414 is also known as daratumumab. The clinical trial NCT02497378 refers to the drug as JNJ-54767414 (Daratumumab). It is being studied in combination with bortezomib and dexamethasone for the treatment of multiple myeloma.