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Daratumumab FDA Approved for Transplant-Eligible Patients With Multiple Myeloma

Multiple myeloma cancer cells.

The FDA has now approved daratumumab (Darzalex®, Janssen) to be used in combination with bortezomib, thalidomide, and dexamethasone (VTd) in adult patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

Daratumumab, a targeted monoclonal antibody, works by attaching itself to a protein called CD38 on multiple myeloma cells. This either directly kills the multiple myeloma cells or allows the body to identify these cells as a foreign invader, therefore attacking and killing them.

Approval was based on the results from the open-label, randomized, active-controlled phase 3 trial, CASSIOPEIA (NCT02541383). In this study, published in The Lancet, 1,085 patients with newly diagnosed multiple myeloma who were transplant-eligible were enrolled. The participants were randomized in a 1:1 ratio to receive either four pre-transplant induction and two post-transplant consolidation cycles of VTd alone or in combination with daratumumab (D-VTd).

At day 100 after patients received a transplantation, a stringent complete response was observed in 29% of the patients in the D-VTd group compared with 20% of patients in the VTd group. For patients who received D-VTd, 39% of them achieved a complete response compared with 26% in the VTd group. In addition, the D-VTd regimen was associated with an improved rate of minimal residual disease-negativity compared with the VTd alone regimen (64% vs 44%). However, median progression-free survival from first randomization was not reached in either group.

The most common side effects, occurring in ≥20% of patients who received D-VTd were infusion reactions, peripheral sensory neuropathy, constipation, asthenia, nausea, peripheral edema, neutropenia, thrombocytopenia, pyrexia, and paresthesia.

For More Information

Clinicaltrials.gov (2019). A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NLM Identifier: NCT02541383

Moreau P, Attal M, Hulin C, et al (2019). Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomized, open-label, phase 3 study. Lancet, 394(10192):29-38. DOI:10.1016/S0140-6736(19)31240-1

Image Courtesy of Wikimedia Commons. Licensed under CC BY-SA 3.0

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