Real-World Outcomes With Generic Pomalidomide in Relapsed Refractory Multiple Myeloma-Experience From a Tertiary Care Cancer Center.

PURPOSE: The prognosis of relapsed and refractory multiple myeloma (RRMM) that is refractory to bortezomib and lenalidomide is very poor wherein the median survival is between 3 and 9 months. We did this retrospective analysis to study the pattern of utilization, tolerance, and outcomes with pomalidomide in these patients having RRMM. MATERIALS AND METHODS: Retrospective analysis of all the patients who were treated with generic pomalidomide at Tata Memorial Centre, Mumbai, during the period of May 2017 to March 2019 was done. Patients with secretory disease and who had completed at least one cycle of pomalidomide were analyzed for response rates, toxicity, and survival outcomes. RESULTS: A total of 81 patients received pomalidomide-based therapy during this study period, out of which 75 were included in the survival analysis. Forty-eight patients (59.3%) were refractory to both lenalidomide and bortezomib. Overall response rate was 58.7%. Five patients (6.7%) achieved complete response, very good partial response was seen in 13 patients (17.3%), and partial response was seen in 26 patients (34.7%). After a median follow-up of 11 months (range 2-27 months), median progression-free survival was 9.1 months (95% CI, 5.4 to 12.9 months). Median progression-free survival for patients who were refractory to both lenalidomide and bortezomib versus nonrefractory was 5.5 and 12.6 months, respectively, which was significant statistically (P = .04, hazard ratio, 0.35, 95% CI, 0.28 to 0.97). The median overall survival was not reached. Important toxicities included anemia (28%), neutropenia (16%), pneumonia (16%), and venous thrombosis (5%). CONCLUSION: Generic pomalidomide-based therapy is an effective option and is well tolerated in patients with RRMM. Higher response rates and longer survival seen in our study are possibly because of heterogeneity of the study population.

Clinical assessment of the autonomic nervous system in diabetes mellitus and its correlation with glycemic control.

AIM: Clinical assessment of the autonomic nervous system in Diabetes mellitus (DM) and its correlation with glycemic control. STUDY DESIGN: Cross sectional study of 50 adult diabetes patients. MATERIALS AND METHODS: Fifty patients with DM who were on regular treatment with either insulin and/or oral hypoglycemic agents were studied. Cardiovascular autonomic neuropathy (CAN) score was calculated using the clinical test variables. RESULTS: Of the 50 patients 30 had no CAN, 10 had early CAN and 10 had severe CAN. The mean of CAN score increased with duration of diabetes. The mean HbA(1C) was 7.73. The mean CAN score was higher in patients who had complication of diabetes as compared to patients without complications. The heart rate variability with respiration was found to be 15.84 ± 7.02/min. The mean valsalva ratio was 1.31 ± 0.23. The mean drop in BP on standing was 7.30 ± 7.24 mmHg. The mean 30:15 ratio was 1.06 ± 0.04. The mean rise in diastolic BP on sustained hand grip was 16.04 ± 4.11 mmHg. CONCLUSIONS: The prevalence of autonomic neuropathy in DM as assessed by CAN score was 40%. The CAN score did not correlate with the duration of DM. The HbA(1C) had a significant correlation with the severity of autonomic neuropathy. Occurrence of CAN correlated with the presence of peripheral neuropathy but not with the presence of retinopathy or nephropathy. All individual tests in the battery of CAN score were significantly associated with the presence of autonomic neuropathy, except 30:15 ratio.