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1963 Quality of Life in the Multicenter, Randomized, Phase 3 GMMG-HD6 Trial Applying Elotuzumab, Lenalidomide, Bortezomib and Dexaemethason in Patients with Newly-Diagnosed Multiple Myeloma

Program: Oral and Poster Abstracts
Session: 653. Multiple Myeloma: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Adult, Human
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Anna Fleischer1*, Elias K. Mai, MD2,3*, Kaya Miah4,5*, Uta Bertsch, MD6*, Britta Besemer, MD7*, Mathias Hänel, MD8, Roland Fenk, MD, PhD9*, Markus Munder10*, Christine Hanoun11*, Igor Wolfgang Blau, MD, PhD12*, Christoph Mann, MD13*, Christof Scheid, MD14, Roland Schroers, MD15*, Ivana von Metzler, MD16*, Aneta Schieferdecker17*, Jörg Thomalla, MD18*, Peter Reimer, MD19,20*, Rolf Mahlberg, MD21*, Ullrich Graeven, MD22*, Stephan Kremers23*, Uwe Martens, MD24*, Christian Kunz25*, Manfred Hensel, MD26*, Marc S. Raab27*, Katja C. Weisel, MD28,29, Hans Salwender, MD30*, Imad Maatouk, MD1* and Hartmut Goldschmidt, MD31,32

1Department of Internal Medicine II, University Hospital Wuerzburg, Wuerzburg, Germany
2Medicine V, University Hospital Heidelberg, Heidelberg, Germany
3Heidelberg Myeloma Center, Department of Medicine V, University Hospital Heidelberg, Heidelberg, Germany
43. Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany., Heidelberg, Germany
5German Cancer Research Center (DKFZ), Heidelberg, DEU
6Department of Medicine V, Heidelberg Myeloma Center, University Hospital Heidelberg, Heidelberg, Germany
7Department of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany
8Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany
9Department of Haematology, Oncology, and Clinical Immunology, University Hospital Düsseldorf, Düsseldorf, Germany
10Third Department of Medicine, University Medical Center of the Johannes Gutenberg University, Mainz, Germany
11Uniklinikum Essen, Essen, DEU
12Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie, Berlin, Germany
13Department of Haematology, Oncology and Immunology, Philipps-University Marburg, Marburg, Germany
14Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany
15Medical Clinic, University Hospital Bochum, Bochum, Germany
16Department of Internal Medicine II, University Hospital Frankfurt a.M., Frankfurt a.M., Germany, Frankfurt am Main, Germany
17Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
18Hematology / Oncology Center, Koblenz, Germany
19Evang. Kliniken Essen-Mitte, Evang. Krankenhaus Essen-Werden, Essen, Germany, Essen, Germany
20Evang. Kliniken Essen-Mitte, Evang. Krankenhaus Essen-Werden, Essen, Germany
21Internal Medicine I, Hospital Mutterhaus der Borromäerinnen, Trier, Germany
22Medical Clinic I, Hospital Maria Hilf GmbH, Mönchengladbach, Germany
23Hematology / Oncology Center, Lebach, Germany
24Hematology, Oncology, Palliative Care, SLK Clinic Heilbronn, Heilbronn, Germany
25Hematology and Oncology, Westpfalz-Klinikum, Kaiserslautern, Germany
26Mannheimer Onkologie Praxis, Mannheim, Germany
27German Cancer Research Center, Heidelberg, Germany
28Universitatsklinikum Tubingen, Hamburg, Germany
29University Medical Center of Hamburg-Eppendorf, Hamburg, Germany
30Asklepios Tumorzentrum Hamburg, Asklepios Hospital Hamburg Altona, Hamburg, Germany
31Internal Medicine V, Hematology, Oncology and Rheumatology, GMMG Studygroup, Heidelberg University Hospital, Heidelberg, Germany
32Department of Medicine V, Heidelberg Myeloma Centre, University Hospital Heidelberg, Heidelberg, Germany; National Centre for Tumour Diseases Heidelberg, Heidelberg, Germany. Electronic address: hartmut.goldschmidt@med.uni-heidelberg.de., Heidelberg, Germany

Background: The addition of elotuzumab to lenalidomide, bortezomib, and dexamethasone (RVd) therapy in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM) did not demonstrate clinical benefit in terms of progression-free survival (PFS; Mai EK et al., 2024, Lancet Haematol.). Assessing the impact of treatment on quality of life (QoL) is crucial in understanding the holistic effects of new therapeutic regimens. Quality of life assessments have become increasingly important in MM management, reflecting a shift towards evaluating both survival outcomes and patient well-being (Fleischer A et al., 2023, J Cancer Res Clin Oncol.).

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.

*signifies non-member of ASH