Session: 653. Multiple Myeloma: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Adult, Human
Methods: QoL assessments were conducted among all 4 study arms in patients who received elotuzumab in addition to RVd induction and/or consolidation and lenalidomide maintenance, compared to those who did not receive elotuzumab (A1 vs. A2+B1+B2). The EORTC-QLQ-C30 and EORTC-QLQ-MY20 questionnaires were administered at baseline, during induction, consolidation, and maintenance phases. Scores were analyzed using weighted generalized estimation equations (WGEE) for longitudinal data with dependent observations. To control the family-wise type I error rate, a fixed-sequence testing procedure was used following FDA guidance. The hierarchical testing sequence for QLQ-C30 scores is specified in the following order: global health status (QL2), pain (PA), fatigue (FA), and emotional functioning (EF).
Results: Data from 2346 QoL assessments across various treatment phases were included in the analysis. At baseline, 476 patients completed the EORTC-QLQ-C30 questionnaire. All evaluated patients showed reduction of PA and improvements in overall QoL across the treatment phases. Notably, there were no significant differences between the study arms in terms of QL2, PA, FA, and EF. Multivariable generalized linear regression analyses incorporating covariates treatment arm (A1 vs. A2+B1+B2) age, sex, WHO performance status, renal insufficiency, fractures, and response after induction therapy showed no significant impact of elotuzumab treatment vs. no elotuzumab treatment arms on QoL scores.
Additionally, specific adverse events such as neuropathy, thromboembolic events, infections, and cardiac disorders were reported and analyzed.
In terms of specific QoL scores, patients' QL2 improved significantly during induction, consolidation, and maintenance phases, with no significant difference between treatment groups. Significant reductions in PA scores were observed during all treatment phases, with consistent improvement across all groups. FA scores showed a significant decrease during all treatment phases, reflecting improved patient well-being over time. EF scores improved significantly across all treatment phases, indicating positive psychological impacts regardless of the treatment group. With respect to prognosis, QL2 at baseline revealed no significant effect on overall survival (OS) and progression-free survival (PFS) in multivariable Cox regression models.
Conclusion: These results suggest that the addition of elotuzumab to RVd-based therapy, followed by lenalidomide maintenance, did not negatively impact the quality of life for transplant-eligible patients with NDMM. Despite variations in treatment regimens, patients reported consistent reductions in pain and improvements in overall QoL. Future studies should continue to focus on QoL and patient-reported outcomes, exploring the intricate relationship between QoL improvements and clinical outcomes in MM treatments.
Disclosures: Mai: Stemline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations and expenses; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations and expenses, Research Funding; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations and expenses, Research Funding; GlaxoSmithKline (GSK): Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations and expenses, Research Funding; Bistol Myers Squibb/Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel expenses, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations and expenses, Research Funding; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees. Besemer: Janssen: Honoraria; Oncopeptides: Honoraria; Takeda: Honoraria; AMGEN: Honoraria; Pfizer: Honoraria; GlaxoSmithKline: Honoraria. Hänel: Sobi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences: Honoraria; Falk Foundation: Honoraria; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kite/Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi-Aventis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer Vital: Consultancy, Membership on an entity's Board of Directors or advisory committees; BristolMyersSquibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BristolMyersSquibb/Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees. Fenk: Pfizer: Honoraria; GlaxoSmithKline (GSK): Other: travel expenses; Janssen: Honoraria, Other: travel expenses; Sanofi: Honoraria; Takeda: Honoraria; BMS/Celgene: Honoraria, Other: travel accommodation and expenses; Amgen: Honoraria. Munder: Takeda: Consultancy; Amgen: Consultancy, Other: Travel Expenses; Stemline therapeutics: Consultancy; Janssen: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Other: Travel expenses; GSK: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria. Mann: BristolMyersSquibb: Consultancy; Celgene: Consultancy; Sanofi: Consultancy; Janssen: Consultancy. Schroers: BMS/Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria; Amgen: Honoraria; Kite/Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees. von Metzler: Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline (GSK): Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees; Stemline: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Raab: Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel expenses, Research Funding; Oncopeptides: Consultancy, Honoraria, Other: travel expenses; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel expenses; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel expenses, Research Funding; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Heidelberg Pharma: Research Funding. Weisel: Roche Pharma: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Other: Research grant to institution; Janssen: Consultancy, Honoraria, Other: Research grant to institution; AstraZeneca: Honoraria; Bristol Myers Squibb/Celgene: Consultancy, Honoraria, Other: Research grant to institution; GlaxoSmithKline: Consultancy, Honoraria, Other: Research grant to institution; AbbVie: Other: Research grant to institution; Adaptive Biotechnologies: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Other: Research grant to institution; BeiGene: Consultancy, Honoraria; Karyopharm: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Menarini: Consultancy, Honoraria; Novartis: Honoraria; Oncopeptides: Consultancy, Honoraria; Stemline: Honoraria; Takeda: Consultancy, Honoraria; Regeneron: Consultancy. Salwender: Chugai: Honoraria; Janssen: Honoraria, Other: Travel grant; Oncopeptides: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria, Other: Travel grant; Stemline: Honoraria; Roche: Honoraria; Takeda: Honoraria; GlaxoSmithKline: Honoraria; Bristol Myers Squibb/Celgene: Honoraria, Other: Travel grant; Amgen: Honoraria, Other: Travel grant; AbbVie: Honoraria; Sebia: Honoraria. Goldschmidt: Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product; support for attending meetings and/or travel, Research Funding; Hoffmann-La Roche: Research Funding; Heidelberg Pharma: Research Funding; Merck Sharp and Dohme (MSD): Research Funding; Karyopharm: Research Funding; Incyte Corporation: Research Funding; Millennium Pharmaceuticals Inc.: Research Funding; Molecular Partners: Research Funding; Novartis: Honoraria, Other: Support for attending meetings and/or travel, Research Funding; MorphoSys AG: Research Funding; Pfizer: Honoraria, Other: Support for attending meetings and/or travel, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; grants and/or provision of Investigational Medicinal Product, Research Funding; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Research Funding; GlycoMimetics Inc.: Research Funding; GlaxoSmithKline (GSK): Honoraria, Other: Support for attending meetings and/or travel, Research Funding; Chugai: Honoraria, Other: Grants and/or provision of Investigational Medicinal Product; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product; support for attending meetings and/or travel, Research Funding; Takeda: Research Funding; Array Biopharma/Pfizer: Other: Grants and/or provision of Investigational Medicinal Product; Bristol Myers Squibb/Celgene: Other: Grants and/or provision of Investigational Medicinal Product; Dietmar Hopp Foundation: Other: Grants and/or provision of Investigational Medicinal Product; Johns Hopkins University: Other: Grants and/or provision of Investigational Medicinal Product; Mundipharma GmbH: Other: Grants and/or provision of Investigational Medicinal Product.
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