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Indian Multicenter Phase Ii Randomised Controlled Study Comparing Post Stem Cell Maintenance Regimen for Newly Diagnosed Multiple Myeloma (Impose Bortecon Study)
Indian Journal of Hematology and Blood Transfusion ; 38(Supplement 1):S8, 2022.
Article in English | EMBASE | ID: covidwho-2175131
ABSTRACT

Introduction:

Autologous stem cell transplant (ASCT) remains the backbone therapeutic modality with the highest progression-free survival (PFS) and overall survival (OS) benefit even in the era of the novel agents in newly diagnosed multiple myeloma (NDMM). The survival post-transplant can be prolonged using maintenance therapies. The regimen with maximum benefit is still debated, with bortezomib showing PFS benefit even in the high-risk myeloma. Aims &

Objectives:

This randomized phase II trial is aimed at studying the efficacy (as measured by overall survival (OS), progression- free survival (PFS)), and safety of post-ASCT different maintenance regimens in patients with NDMM. Material(s) and Method(s) Multicentric open-label interventional study with randomized allocation, parallel assignment, with intention-totreat analysis. Recruitment was prospective starting 01 Jan 2017, including all NDMM patients eligible for the study. Remission status was evaluated at D100 and every 6 months for 2y post-ASCT, including MRD analysis by multicolor flow cytometry (MFC) and PET/CT. The four arms included (Arm-A) bortezomib alone (V), (Arm-B) bortezomib in combination with cyclophosphamide and dexamethasone (VCD), (Arm-C) bortezomib in combination with lenalidomide (VR), and (Arm-D) Lenalidomide starting D100 till 2y post-ASCT. Adverse events with CTACE grade<2 were defined as non-serious and the rest as serious. JMP ver. 13 was used for statistical analysis and p<0.05 was considered significant. Kaplan Meier statistics was used for survival analysis. Result(s) A total of 123 patients have enrolled of which 92 patients completed the study protocol and the rest 31 patients were excluded because of protocol deviation due to the COVID pandemic. The median age of the study population was 54.5y (35-76y) with a male preponderance (67%). There was no statistically significant difference between the four arms on the log-rank test in the OS (p-0.99), clinical PFS (p-0.65), biochemical PFS (p-0.6), or MFC-based PFS (p-0.83). There was a statistically significant difference between the four arms on the log-rank test (p-0.0185) on PET/CT-based PFS (PFS being in a descending order VCD>V>VR>R regimen). The all-cause mortality of the study participants was 19.57% (n-18) and the difference in deaths among the various groups was not statistically significant (p-0.85). The tolerability, serious and non-serious adverse were significantly higher amongst Arm D patients. Conclusion(s) We conclude that there was no difference in OS between the different regimens. Patients on Lenalidomide-only therapy had significantly inferior Imaging-PFS.
Keywords

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: Indian Journal of Hematology and Blood Transfusion Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: Indian Journal of Hematology and Blood Transfusion Year: 2022 Document Type: Article