Results From MAIA Study May Open New Doors for Patients With Multiple Myeloma

Daratumumab plus lenalidomide and dexamethasone is more beneficial than standard therapy alone for patients with newly diagnosed multiple myeloma who are not eligible for stem-cell transplantation, according to new study results presented at the American Society of Hematology’s 2021 Annual Meeting and Exposition.

The MAIA study was a phase 3 trial comparing lenalidomide and dexamethasone alone with daratumumab as an add-on therapy to lenalidomide and dexamethasone in patients with transplant-ineligible newly diagnosed multiple myeloma.

To conduct the study, the researchers enrolled patients who had a new diagnosis of multiple myeloma and were ineligible for high-dose chemotherapy and autologous stem-cell transplantation because of older age or comorbidities.

Participants were then randomly assigned 1:1 to receive either daratumumab plus lenalidomide and dexamethasone (n = 368) or lenalidomide and dexamethasone alone (n = 369). Both groups received 28-day cycles of oral lenalidomide and dexamethasone. The daratumumab group also received intravenous daratumumab one weekly for cycles 1 and 2, once every 2 weeks for cycles 3 to 6, and once every 4 weeks after that.

The primary endpoint was progression-free survival. Therefore, patients received treatment until their disease progressed or they experienced unacceptable safety events. The secondary end point was overall survival.

Overall, 162 (44%) patients in the daratumumab group and 142 (38%) in the lenalidomide and dexamethasone group had renal impairment, defined as a baseline creatinine clearance of 60 mL/min or less. After a median follow-up period of 56.2 months, dexamethasone improved progression-free survival and overall survival, regardless of starting lenalidomide dose.

Among participants in the lenalidomide, 25 mg subgroup who died, disease progression was the primary cause of death in 6 (50%) taking daratumumab and 10 (34%) taking standard therapy. Among participants in the lenalidomide, less than 25 mg subgroup who died, disease progression was the primary cause of death in 16 (36%) taking daratumumab and 11 (30%) taking standard therapy.

“Many transplant-ineligible patients with [newly diagnosed multiple myeloma] may not receive a second line of therapy; our results support the frontline use of [daratumumab plus lenalidomide and dexamethasone] to provide prolonged disease control in transplant-ineligible patients with [newly diagnosed multiple myeloma] and renal impairment,” the researchers concluded.

—Amanda Balbi

Reference

Usmani SZ, Kumar SK, Plesner T, et al. Efficacy of daratumumab, lenalidomide, and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma and impaired renal function from the phase 3 MAIA study based on lenalidomide starting dose. Paper presented at: American Society of Hematology’s 2021 Annual Meeting and Exposition; December 11-14, 2021; Virtual. https://ash.confex.com/ash/2021/webprogram/Paper146940.html