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1. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone: Update of the Phase 3 MAIA Trial

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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2. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post Hoc Analyses from MAIA

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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3. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post HocAnalyses from MAIA

Author

Perrot, Aurore, Facon, Thierry, Kumar, Shaji, Plesner, Torben, Orlowski, Robert Z., Moreau, Philippe, Bahlis, Nizar J., Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O'Dwyer, Michael E., Venner, Chris P., Weisel, Katja, Mace, Joseph R., Raje, Noopur S., Tiab, Mourad, Macro, Magaret, Frenzel, Laurent, Leleu, Xavier, Liu, Kevin, Fastenau, John, Gries, Katharine S., Ho, Kai Fai, Mistry, Pankaj, Tromp, Brenda, Delioukina, Maria, Vermeulen, Jessica, and Usmani, Saad Z.

Abstract

Introduction:In oncology clinical trials, overall survival (OS) is considered the gold standard efficacy endpoint. However, in multiple myeloma, the prolonged survival times and availability of multiple salvage therapies render it difficult to rely on OS as a primary endpoint. Instead, progression-free survival (PFS) or clinical response can be a relevant biomarker. At the same time, some health technology assessment bodies will only consider evidence based on patient-relevant endpoints, such as morbidity, mortality, and health-related quality of life (HRQoL), within their benefit assessments. Patient-reported outcomes (PROs) provide insights into how a treatment affects HRQoL, including symptoms and functioning. In the phase 3 MAIA trial, daratumumab, lenalidomide, and dexamethasone (D-Rd) demonstrated a significantly prolonged PFS and rapid and sustained improvements in PROs compared with lenalidomide and dexamethasone (Rd) alone at a median follow-up of 28 months. Updated results with longer follow-up confirmed a continued PFS benefit, deepening best clinical responses, and a significant OS benefit with D-Rd. Here, we report the results of analyses exploring the relationship between clinical efficacy endpoints and PROs in the MAIA trial.

Published
2021
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