Deepmala Mazumdar

Summary: SeaLAND (ALLG MM23, ACTRN12620000291987) was a randomized, open‐label phase III study evaluating low‐dose weekly selinexor (40 mg) plus lenalidomide (selinexor‐R) versus lenalidomide alone (R) as post‐transplant maintenance therapy for newly diagnosed, transplant‐eligible multiple myeloma. A total of 142 patients were enrolled (R = 64; selinexor‐R = 78); the trial closed early for futility. At best response, the complete response (≥CR) rate was numerically, but not significantly, higher with selinexor‐R than R (67% vs. 53%, p = 0.09). At 24 months median follow‐up, progression‐free survival (PFS) was not significantly different between selinexor‐R compared to R (hazard ratio [HR] = 1.22; 95% confidence interval [CI] 0.62–2.41; p = 0.56); 24‐month PFS rates were 73% (95% CI 57%–84%) for R and 70% (95% CI: 56%–81%) for selinexor‐R. The mean relative dose intensity (RDI) of R was lower in the selinexor‐R arm compared to R alone (68% vs. 81%, p = 0.002); the mean RDI of S was 55%. Grade ≥3 adverse events were more frequent with selinexor‐R (85% vs. 45%, p < 0.001). Common severe non‐haematological adverse events included infections (R: 6%, selinexor‐R: 19%, p < 0.01) and gastrointestinal disorders (R: 3%, selinexor‐R: 14%, p < 0.05). Selinexor‐R maintenance did not improve PFS and substantially increased toxicity. Selinexor‐R maintenance cannot be recommended for the general myeloma population; we did not observe a benefit among high‐risk disease.

SIGNIFICANCE: This study explains the construction and validation of a chart in Hindi language, one of the commonly spoken languages in the world. The new visual acuity chart is called LEA Hindi chart. The calligraphy construction method described here can help develop other such acuity charts. PURPOSE: The purpose of this study was to construct and validate a new logMAR Hindi visual acuity chart (LEA Hindi chart) using principles similar to that of LEA symbols acuity chart. METHODS: A multicenter (three centers) study was conducted in two phases. The first phase consisted of identifying and constructing the Hindi optotypes using calligraphy techniques. The Hindi optotypes were calibrated against the Landolt C optotypes by measuring the threshold distance for visual acuity. In the second phase, the newly constructed LEA Hindi chart was validated against the Early Treatment Diabetic Retinopathy Study (ETDRS) and Landolt C visual acuity charts. Sixty participants were enrolled for the first phase (centers 1 and 2) and for the second phase of the study (centers 1 and 3). Additional 15 participants were enrolled (center 1) for testing repeatability. RESULTS: Four Hindi optotypes were identified and used for the construction of the chart (first phase). In the second phase, the LEA Hindi chart was found to be comparable with both the Landolt C, (logMAR acuity difference, 0.03 ± 0.13; P >. 18) and ETDRS (logMAR acuity difference, −0.02 ± 0.09; P >. 25) charts. All the three charts were also found to be repeatable (95% limits of agreement within 0.24 logMAR). CONCLUSIONS: The newly constructed LEA Hindi visual acuity chart gave comparable levels of visual acuity as that measured in an ETDRS or Landolt C charts. The repeatability was also similar to the standard charts. The LEA Hindi visual acuity chart can be used for patients comfortable with Hindi language and also in studies requiring multiple measurements of visual acuity, to avoid familiarity to a given chart.