From the Guidelines
Darzalex treatment should be continued indefinitely, or until disease progression or unacceptable toxicity occurs, as part of a long-term treatment plan for relapsed/refractory multiple myeloma, based on the latest evidence from the NCCN clinical practice guidelines in oncology 1. The decision to continue Darzalex forever is supported by the results of the POLLUX trial, which demonstrated improved progression-free survival (PFS) and overall response rate (ORR) in patients with relapsed/refractory multiple myeloma who received daratumumab in combination with lenalidomide and dexamethasone 1. Key points to consider when making this decision include:
- The median PFS was 16.7 months with the daratumumab regimen versus 7.1 months with lenalidomide/dexamethasone alone 1
- The ORR was 92.9% with the daratumumab regimen versus 76.4% with lenalidomide/dexamethasone alone 1
- The most common adverse events of grade 3 or 4 were neutropenia, thrombocytopenia, and anemia, but daratumumab-associated infusion-related reactions were mostly grade 1 or 2 1 Regular monitoring through blood tests and clinical evaluations is essential to assess ongoing effectiveness and safety, and treatment decisions should always be individualized based on the patient's response, side effects, and overall health status in consultation with their hematologist/oncologist.
From the FDA Drug Label
The safety data described below reflects exposure to DARZALEX (16 mg/kg) in 2,459 patients with multiple myeloma including 2,303 patients who received DARZALEX in combination with background regimens and 156 patients who received DARZALEX as monotherapy
The FDA drug label does not answer the question.
From the Research
Darzalex Treatment Duration
- The treatment duration for Darzalex (daratumumab) varies depending on the specific regimen and patient population 2, 3, 4, 5.
- In the study by 2, patients with relapsed or relapsed and refractory multiple myeloma received daratumumab in combination with bortezomib and dexamethasone for a median of 7.4 months.
- In the CEPHEUS trial 3, patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma received subcutaneous daratumumab plus bortezomib, lenalidomide, and dexamethasone for eight cycles, followed by daratumumab plus lenalidomide and dexamethasone until progression.
- The PERSEUS trial 4 evaluated the addition of subcutaneous daratumumab to bortezomib, lenalidomide, and dexamethasone induction and consolidation therapy, and to lenalidomide maintenance therapy, in transplantation-eligible patients with newly diagnosed multiple myeloma.
Efficacy and Safety
- The studies demonstrate that daratumumab-based regimens are effective in improving progression-free survival and overall response rates in patients with multiple myeloma 2, 3, 4, 5.
- However, the regimens are also associated with increased adverse events, such as infusion-related reactions, thrombocytopenia, and neutropenia 2, 3, 4, 5.
- The cost-effectiveness analysis by 6 suggests that daratumumab-based regimens may not be cost-effective compared to standard therapy, although further analysis is needed to confirm this finding.
Treatment Outcomes
- The studies show that daratumumab-based regimens can achieve high response rates, including complete response and minimal residual disease negativity 3, 4, 5.
- The GRIFFIN trial 5 demonstrated that the addition of daratumumab to lenalidomide, bortezomib, and dexamethasone improved the stringent complete response rate and minimal residual disease negativity rate in transplant-eligible patients with newly diagnosed multiple myeloma.