Results of the CARTITUDE-1 study presented at the 48th Annual Oncology Nursing Society Congress in San Antonio, Texas demonstrated that after treatment with ciltacabtagene autoleucel (cilta-cel), sustained minimum residual disease (MRD)-negative status was associated with greater duration of response (DOR) and progression free survival (PFS) in patients with relapsed/refractory multiple myeloma (RRMM).
Ciltacabtagene autoleucel is a chimeric antigen receptor-T cell (CAR-T) therapy used in the treatment of patients with RRMM who have undergone at least 3 prior lines of therapy. In the CARTITUDE-1 study, cilta-cel was given to patients who met these criteria in a single infusion. The patients’ bone marrow samples were assessed using next-generation sequencing (NGS) at baseline to screen for myeloma clones—cells with gene mutations. Bone marrow was tested again at day 28 and months 6, 12, 18, and 24 posttreatment to determine the presence of these mutated cells. Patients were considered to have achieved MRD-negative status if the count of myeloma clones in the bone marrow aspirate was <1 mutated cell per 105 nucleated cells.
Of 97 patients included in the study, 61 had aspirate samples that met quality standards for MRD testing via NGS. Although most (n=56) achieved MRD-negativity, only 24 demonstrated sustained negativity for ≥12 months. Of the remaining 32 patients, 10 demonstrated 6-12 months of MRD-negativity, and 22 were MRD-negative for <6 months.
“Patients with sustained MRD negativity had longer median (95% CI) DOR (6-12 months: NE [12.5 mo, NE]; ≥12 months: NE [NE, NE]) and PFS (6-12 months: NE [13.4 months, NE]; ≥12 months: NE [NE, NE]) compared with patients with sustained MRD negativity for <6 months (DOR: 10.3 months [5.1, 15.6]; PFS: 11.0 months [5.4, 16.6]),” the poster presented at ONS reported.
These results indicate that sustained MRD-negativity is associated with more favorable outcomes. The study authors encourage baseline and follow-up bone marrow aspirate NGS as the results can be clinically meaningful and useful to nurses and their patients.
Aronson E, Madduri D, Suarez J, et al. Minimal residual disease negativity as a measure of response to ciltacabtagene autoleucel in patients with relapsed or refractory multiple myeloma. Abstract #P374. Presented at the 48th Annual ONS Congress; San Antonio, TX, April 26-30, 2023.