Search

Background: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved., Methods: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria., Results: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified., Conclusions: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.)., (Copyright © 2024 Massachusetts Medical Society.)

Objective: To assess the effectiveness of suture button fixation Latarjet procedure under total arthroscopy for anterior shoulder instability with severe bone defects., Methods: The clinical data of 15 patients with severe bone defects and anterior shoulder instability treated with suture button fixation Latarjet procedure under total arthroscopy between June 2020 and February 2023 was retrospectively analyzed, including 11 males and 4 females, with an average age of 31.1 years (range, 20-54 years). Three-dimensional CT showed that the average glenoid bone defect was 24.4% (range, 16.3%-35.2%). The average number of shoulder dislocation was 4.2 times (range, 3-8 times). The disease duration ranged from 6 to 21 months with an average of 10.6 months. The operation time and intraoperative blood loss were recorded. The pain relief was evaluated by visual analogue scale (VAS) score, and the functional recovery of shoulder joint was evaluated by Rowe score, Walch-Duplay score, and American Association for Shoulder and Elbow Surgery (ASES) score before and after operation. The range of motion (ROM) of the shoulder joint was assessed, including active flexion, lateral external rotation, abduction 90° external rotation, and internal rotation. Three-dimensional CT was performed at 6 months after operation and at last follow-up to observe the absorption of bone graft, the position of bone graft and glenoid, and the healing of bone graft., Results: The operation was successfully completed in all patients. The operation time was 85-195 minutes, with an average of 123.0 minutes. The intraoperative blood loss was 20-75 mL, with an average of 26.5 mL. All patients were followed up 13-32 months, with an average of 18.7 months. During the follow-up, there was no serious complication such as shoulder joint infection, joint stiffness, or vascular and nerve injury. One patient had partial absorption of the transplanted bone and bone nonunion at 3 months after operation, but the pain of the shoulder joint relieved at last follow-up, and no redislocation of the shoulder joint occurred; no obvious bone fracture or dislocation of the shoulder joint was found in the other patients. Bone union was achieved at 6 months during follow-up. At last follow-up, the VAS score, Rowe score, Walch-Duplay score, and ASES score significantly improved when compared with those before operation ( P <0.05), while the ROM of active flexion, lateral external rotation, abduction 90° external rotation, and internal rotation of the shoulder joint was not significantly different from those before operation ( P >0.05)., Conclusion: Suture button fixation Latarjet procedure under total arthroscopy can improve shoulder joint function in patients with severe anterior shoulder instability caused by bone defects, and imaging also indicates satisfactory placement of transplanted bone blocks.