Summary
Treatment of patients with resistant/refractory multiple myeloma (MM) is an unmet need. In this phase II study, we evaluated the role of bendamustine, pomalidomide and dexamethasone combination in this setting. Between February 2020 and December 2021, 28 patients were recruited. Patients received bendamustine 120 mg/m2day 1, pomalidomide 3 mg days 1–21, and dexamethasone 40 mg days 1, 8, 11, 22, regimen given for a maximum of six cycles. The median (range) age of the patients was 54 (30–76) years and 15 (53.6%) were males. Patients had received a median (range) of three (two–six) prior lines and 85.7% were refractory to both lenalidomide and bortezomib. The primary end‐point was the overall response rate (ORR) defined as ≥partial response after at least three cycles. Secondary objectives were toxicity, progression‐free survival (PFS), time to progression and overall survival (OS). An intent‐to‐treat analysis was done. An ORR of 57.6% was achieved. Patients with extramedullary myeloma had a better response rate. At a median follow‐up of 8.6 months, the median PFS and OS were 6.2 and 9.7 months respectively. Toxicity was manageable; mainly haematological (neutropenia, 46.4%; anaemia, 42.8%; and thrombocytopenia, 7.1%). Bendamustine, pomalidomide and dexamethasone could be a novel combination for the heavily pretreated, lenalidomide‐refractory myeloma population.
Immune check point inhibitors such as nivolumab are changing the treatment paradigm of relapsed/refractory Hodgkin lymphoma (r/rHL). Data from single arm studies have shown nivolumab to be an effective and safe therapy. Real world data from resource constrained settings are limited. Our study is a retrospective single center analysis of nivolumab in r/rHL from India. Data regarding baseline and pretreatment characteristics were collected for 20 patients treated with nivolumab from January 2016 to March 2021. Of 20, 15 patients received nivolumab in modified protocol, because of financial limitations. Postnivolumab therapy, the overall response rate was 90%, with 40% in complete remission. The median progression free survival was 13.1 month (95% confidence interval 8.33 mo, not reached) and median overall survival not reached, at a follow up of 24.3 months. No patients discontinued nivolumab because of side effects. Univariate and multivariate analysis showed no effect of dose reduction or increased duration of administration. Most common adverse effect seen was autoimmune hypothyroidism. Possible delayed immune-related side effects were seen in 3 out 5 patients in peritransplant period, in those who received nivolumab as salvage regimen before autologous stem cell transplant. In conclusion, nivolumab shows comparable efficacy and safety even with compromised dosing and schedule of administration of the drug in real world setting.
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