Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daratumumab: daratumumab+ rHuPH20 · 1 trial · 1 indication
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
| Arm | Type | Description |
|---|---|---|
| Arm A: Active Monitoring | NO_INTERVENTION | Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab. |
| Arm B: Daratumumab SC | EXPERIMENTAL | Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. |
| Name | Type | Description |
|---|---|---|
| Daratumumab SC: daratumumab + rHuPH20 | DRUG | Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 \[2000 U/mL\]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration. |
Inclusion Criteria: * Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group \[IMWG\] criteria) for less than or equal to (\<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (\>=) 10 gram ...
Daratumumab+ rHuPH20 is used for the treatment of smoldering multiple myeloma, a condition characterized by high-risk features. It is administered subcutaneously and is being studied in patients aged 18 years and older. The drug is currently in Phase 3 clinical development for this indication.
Daratumumab+ rHuPH20 is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is being investigated for the treatment of smoldering multiple myeloma and is currently in Phase 3 clinical trials.
Daratumumab+ rHuPH20 is in Phase 3 clinical development for the treatment of smoldering multiple myeloma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions.
Daratumumab+ rHuPH20 is being studied in a Phase 3 clinical trial with the identifier NCT03301220. This trial, titled 'A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma,' enrolled 390 participants and has been completed. The study was conducted across multiple countries, including the United States, Argentina, Australia, and others.
Daratumumab+ rHuPH20 is a combination of daratumumab, a monoclonal antibody that targets CD38 on the surface of multiple myeloma cells, and recombinant human hyaluronidase (rHuPH20), which facilitates subcutaneous administration. The daratumumab component binds to CD38, leading to immune-mediated destruction of myeloma cells.
Daratumumab+ rHuPH20 is a formulation that combines daratumumab with recombinant human hyaluronidase (rHuPH20) to allow for subcutaneous injection. While the active antibody is the same as intravenous daratumumab, the addition of rHuPH20 enables a different route of administration, potentially offering convenience and shorter infusion times.