Rebecca Silbermann, MD, MMS, of the Knight Cancer Translational Oncology Program, Oregon Health & Science University, discusses patient reported outcomes from the phase 2 GRIFFIN trial, assessing daratumumab plus lenalidomide, bortezomib, and dexamethasone (D-RVd) in newly diagnosed multiple myeloma patients. The patient reported income data were recently presented at this year’s American Society of Hematology Meeting & Exposition (ASH 2022).

Multiple myeloma is a rare blood cancer associated with uncontrolled growth of plasma cells. Abnormal plasma cells – also known as myeloma cells – interfere with the production of healthy blood cells in the bone marrow. Myeloma cells also produce inactive clones of abnormal antibodies that may negatively affect the bones and kidneys. Symptoms of multiple myeloma may include: bone pain (particularly in the chest and spine), frequent infections, weakness or numbness in the legs, fatigue, confusion, excessive thirst, and constipation. While the disease is treatable, relapses are common and some patients are refractory to first line treatment.

As Dr Silbermann explains, GRIFFIN was a randomized, open-label, active-controlled, phase 2 study comparing D-RVd and RVd in transplant-eligible patients with newly diagnosed multiple myeloma. 

Presented at ASH 2022 were patient-reported outcomes from GRIFFIN at the final study analysis after all patients completed 1 year of follow-up post maintenance therapy with 49.6 months of median follow-up.

Patient-reported outcomes 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. Questionnaires were completed at baseline, on day 1 of cycles 2, 3, 5, on day 21 of cycle 4, post-ASCT consolidation, and after months 6, 12, 18 and 24 of maintenance. 

A total of 207 patients were randomized (D-RVd, n=104; RVd, n=103). Compliance rates for all PRO questionnaires were >81% at baseline, 62.6% in the D-RVd group and 48.6% in the RVd group post-ASCT consolidation, and decreased with follow-up during the maintenance phase (maintenance month 24: D-RVd, 49.4%; RVd, 45.1%). Mean baseline values for QLQ-C30 Global Health Status (GHS), functional and symptom subscales and EQ-5D-5L Visual Analog Scale (VAS) were comparable between the D-RVd and RVd groups. Least squares (LS) mean change from baseline improved for GHS and physical functioning during the maintenance phase in the D-RVd group and was numerically greater with D-RVd vs RVd (maintenance Month 24, LS mean change for GHS: 13.2 vs 8.8; LS mean change for physical functioning: 21.6 vs 11.6, p=0.0158). Reduction in pain symptoms was seen at most time points for patients in both treatment arms, with a large reduction (≥20-point change) in pain in favor of D-RVd at post-ASCT consolidation and throughout the maintenance phase (maintenance Month 24 [LS mean change: -29.7 vs -18.4; p=0.0497). Patients treated with D-RVd experienced a greater reduction in fatigue symptoms at maintenance Month 6 than those treated with RVd (LS mean change: -13.5 vs -5.0; p=0.0347). Similarly, EQ-5D-5L VAS was higher with D-RVd vs RVd at month 18 of maintenance. Improvements from baseline were seen in EORTC QLQ MY20 disease symptoms and future perspective for both treatment groups and generally favored D-RVd at several time points. Median time to first worsening in GHS was 45.2 months vs 14.4 months with D-RVd vs RVd.

Overall, the addition of daratumumab to RVd resulted in greater improvements in health-related quality of life for patients who continued on maintenance treatment post-ASCT consolidation compared to RVd alone, with a notable reduction in pain symptoms. These findings further support the addition of daratumumab to RVd in transplant-eligible patients with newly diagnosed multiple myeloma without compromise of health-related quality of life. 

To learn more about multiple myeloma and other rare cancers, visit checkrare.com/diseases/cancers/