Single arm, multicentre study of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM) - MM18

Full description

- MM18 is an International study in collaboration with Asian Myeloma Network (AMN). - The overall number of participants planned was 100 (50 patients from ALLG sites and 50 from AMN sites). - Overall, the trial recruited 93 patients altogether (50 patients from ALLG sites and 43 patients from AMN sites). - The study included male and female patients, ≥18 years of age (*For Singapore, Male and female patients, ≥21 years of age). - This study was aimed for relapsed and/or refractory multiple myeloma with up to 3 lines of prior treatment. - The study aimed to assess the progression free survival in patients with RRMM who have had 1 to 3 prior therapies treated with combination carfilzomib, thalidomide and dexamethasone. Data types - Data set included 90 patients, as 3 patients were excluded due to screen failures. Cancer Australia demographic data -Year of birth -Aboriginal or Torres Strait Islander status (or Ethnicity) - Disease response collected as per IMWG criteria - Quality of life (EuroQoL EQ-5D-5L) was collected - Follow up data collected every 12 weeks. - ECOS performance status was assessed for all 90 patients throughout the study until follow up. - There were 2 interim analyses and a main analysis conducted. The first interim analysis was conducted on 02 August 2017 with 10 participants on study to assess safety. The second interim analysis was conducted on 28 April 2020. The analysis population for the second interim analysis was all patients that received at least one dose of carfilzomib and who could be assessed for the primary endpoint of PFS. Overall, 68 patients were evaluated for the second interim analysis (49 from Australia and 19 from Asian Myeloma Network). The final analysis was conducted on 12 May 2023 following the completion of the last patient’s final cycle of maintenance treatment.

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