Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DARA · 2 trials · 1 indication
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required.
Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
An adverse event (AE) is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
| Arm | Type | Description |
|---|---|---|
| Dara SC | EXPERIMENTAL | Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. |
| Dara IV | ACTIVE_COMPARATOR | Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator. |
| Name | Type | Description |
|---|---|---|
| Dara SC | DRUG | Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. |
| Dara IV | DRUG | Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. |
Inclusion Criteria: * Evidence of a response (Partial response \[PR\] or better based on investigator's determination of response by international myeloma working group \[IMWG\] criteria) to at least 1 prior treatment regimen * Received at least 3 prior lines of therapy including a proteasome inhib...
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DARA is a small molecule being developed by Johnson & Johnson for the treatment of multiple myeloma. It is currently in Phase 3 clinical development for this indication. DARA is an investigational drug and has not been approved by regulatory authorities.
DARA targets CD38, a protein commonly expressed on multiple myeloma cells. By binding to CD38, DARA is designed to help the immune system attack and destroy cancer cells. This mechanism is being evaluated in clinical trials for patients with relapsed or refractory multiple myeloma.
DARA is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate DARA as a treatment for multiple myeloma.
DARA is in Phase 3 clinical development for multiple myeloma. The Phase 3 trial, NCT03277105, compared subcutaneous versus intravenous administration of daratumumab in patients with relapsed or refractory multiple myeloma. This trial has been completed.
DARA has been studied in two completed clinical trials. NCT03277105 was a Phase 3 study comparing subcutaneous versus intravenous administration of daratumumab in 522 patients with relapsed or refractory multiple myeloma. NCT03242889 was a Phase 1 study of subcutaneous delivery in 6 Japanese participants with the same condition.
Yes, DARA is also known as daratumumab. The clinical trials for DARA, including NCT03277105 and NCT03242889, specifically study daratumumab in patients with multiple myeloma. This alternative name is used in the scientific literature and trial registries.