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 plus rHuPH20 is a subcutaneous formulation that combines daratumumab, a monoclonal antibody, with rHuPH20, which is used to enable subcutaneous administration. It is being developed by Johnson & Johnson (ticker JNJ) for the treatment of smoldering multiple myeloma, a precursor condition to active multiple myeloma.
Daratumumab plus rHuPH20 is being studied for smoldering multiple myeloma, an asymptomatic precursor to multiple myeloma. The clinical program focuses on patients with high-risk smoldering multiple myeloma, a group at elevated risk of progressing to active disease. It is an investigational use and has not been established as an approved indication.
Daratumumab plus rHuPH20 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor of the clinical program evaluating the subcutaneous daratumumab combination in smoldering multiple myeloma.
Daratumumab plus rHuPH20 is in Phase 3 development for smoldering multiple myeloma. The Phase 3 trial in this program has been completed. The drug is investigational and is not approved for this indication.
Daratumumab plus rHuPH20 has been evaluated in the Phase 3 trial NCT03301220, titled A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. The trial enrolled 390 participants across the United States, Europe, Asia, Latin America, Australia, and Turkey, and it has been completed.
Yes. Daratumumab plus rHuPH20 is also known as daratumumab SC, or subcutaneous daratumumab. The rHuPH20 component is a recombinant human hyaluronidase used in the subcutaneous formulation, so the two names refer to the same subcutaneous daratumumab product.