The benefit of adding daratumumab to the PI-based triplet bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients with multiple myeloma who underwent high dose melphalan chemo and autologous hemopoietic cell transplant was assessed.
In order to assess the safety and effectiveness of carfilzomib, lenalidomide, dexamethasone, daratumumab combination therapy for newly diagnosed patients with multiple myeloma, in the absence of high-dose melphalan chemo and autologous hemopoietic cell transplant. According to the clinical and correlative pilot carried out study at the Memorial Sloan Kettering Cancer Center in New York, New York, Newly diagnosed Patients with multiple myeloma were enrolled b/w October 1, 2018, and November 15, 2019. The median follow up from the initiation of the treatment was noted as 20.3 months (95 percent CI, 19.2 to 21.9 months). Eight 28-day cycles along with the intravenous carfilzomib, 20/56 mg/m2 (days 1, 8, and 15); oral lenalidomide, 25 mg, (days 1 to 21); dexamethasone, 40 mg weekly, orally or intravenously (cycles 1 to 4), and 20 mg following cycle 4; and intravenous daratumumab, 16 mg/kg (days 1, 8, 15, and 22 [cycles 1 to 2]; days 1 and 15 [cycles 3 to 6]; and day 1 [cycles 7 and 8]). The observed primary endpoint was the MRD (minimal residual disease) rate, in absence of high-dose melphalan chemo and autologous hemopoietic cell transplant. Secondary endpoints included determining safety as well as tolerability, evaluation rates of the clinical response per the International Myeloma Working Group, and estimating PFS and the overall survival rates. Total of 41 assessable patients were enrolled (median age, 59 years; range, 30 to 70 years); 25 (61 percent) enrolled patients were female, and 20 (49 percent) had high-risk MM. Primary endpoint (minimal residual disease negativity in the bone marrow; 10 to 5 sensitivity) was reached in 29 of 41 patients (71%; 95% CI, 54 percent to 83 percent), and thus the trial was deemed completed. The median time to minimal residual disease negativity was six cycles (range, 1 to 8 cycles). Secondary end points of the overall response rate and the VGPR or CR rate were 100 percent (41 of 41 patients) and 95 percent (39 of 41 patients), respectively. At eleven months of the median follow-up, the one year progression free survival rate and the overall survival rate was noted as 98 percent (95 percent CI, 93 percent to 100 percent) and 100 percent, respectively. The most commonly reported grade 3/4 adverse events were neutropenia, rash, lung infection, and increased alanine aminotransferase level. Though, no casualties were reported. In this nonrandomized clinical trial, carfilzomib, lenalidomide, dexamethasone, daratumumab combination therapy was linked with the high rates of minimal residual disease negativity in newly diagnosed patients with the multiple myeloma and the high rates of progression-free survival. Reference: https://pubmed.ncbi.nlm.nih.gov/33856405/
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AuthorMy Name is Amit Sharma I am a pharmacist, I am having 25+ years of experience in Pharma medications. ArchivesCategories
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