Results of patient-reported outcomes from the GRIFFIN study showed improved health-related quality of life in patients with NDMM with the addition of daratumumab to lenalidomide, bortezomib, and dexamethasone.
GRIFFIN is a multicenter, phase 2 study of daratumumab plus bortezomib, lenalidomide, and dexamethasone (D-RVd) versus RVd alone in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). After a median follow-up of 49.6 months, D-RVd led to a significant progression-free survival benefit versus RVd alone. All patients completed 2 years of maintenance therapy where D-RVd continued to demonstrate deeper responses and improved minimal residual disease negativity compared to RVd alone. At the 2022 American Hematology Society meeting, Rebecca Silbermann presented patient-reported outcomes (PROs) from the final analysis of the GRIFFIN study after all patients completed >1 year of treatment.
PROs were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20-item (EORTC QLQ-MY20), and EuroQol 5-dimensional (EQ-5D-5L) descriptive system. Analysis was conducted on all randomized patients, and questionnaires were completed at baseline, during, and after autologous stem-cell transplant (ASCT) consolidation and after months 6, 12, 18, and 24 of maintenance. A total of 207 patients were randomized: 104 to D-RVd and 103 to RVd. For all questionnaires, completion rates were over 81% at baseline, 63% versus 49% at post-ASCT consolidation in the D-RVd versus RVd groups, and 49% versus 45% at follow-up during the maintenance phase. EORTC QLQ-C30 global health status (GHS), functional and symptom subscales, and EQ-5D-5L visual analog scale (VAS) were comparable between the 2 groups at baseline. Mean change from baseline improved during the maintenance phase for GHS and physical functioning in the D-RVd and RVd groups. At most time points in both arms, a reduction in pain symptoms was seen with a ≥20-point change in favor of D-RVd at post-ASCT consolidation and throughout the maintenance phase. At maintenance month 6, a larger reduction in fatigue symptoms was seen with D-RVd versus RVd, and EQ-5D-5L VAS was higher at maintenance month 18 with D-RVd. Reduction in disease symptoms was observed with both treatments and favoring D-RVd at most time points. After a median follow-up of 49.6 months, the median time to first worsening in GHS was 45.2 months in the D-RVd group and 14.4 months in the RVd group, median time to worsening of disease symptoms and utility scores was not reached in the D-RVd arm, there was no difference in the median time to treatment with worsening of EQ-5D-5L VAS, and median time to worsening of treatment side effects was more than double with D-RVd.
In addition to its clinical benefit, D-RVd showed greater improvements in PROs for patients who continued on maintenance post-ASCT consolidation. These results continue to support the use of D-RVd in transplant-eligible NDMM patients.
Reference
- Silbermann R, Laubach J, Kaufma JL, et al. Health-related quality of life in transplant-eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: patient reported outcomes from GRIFFIN. Presented at: 2022 American Society of Hematology Annual Meeting; December 10-13; New Orleans, LA. Abstract 652.
