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. 2024 May 17;5(3):494-504.
doi: 10.1002/jha2.925. eCollection 2024 Jun.

QoL during KTd or KRd induction followed by K maintenance or observation in transplant noneligible patients with newly diagnosed multiple myeloma: Longitudinal and cross-sectional analysis of the randomized AGMT 02 study

Heinz Ludwig  1 , Thomas Melchardt  2 , Ilvy Schweitzer  1 , Siegfried Sormann  3 , Martin Schreder  4 , Johannes Andel  5 , Bernd Hartmann  6 , Niklas Zojer  4 , Laurenz Schöffmann  7 , Eberhard Gunsilius  8 , Klaus Podar  9 , Alexander Egle  2 , Wolfgang Willenbacher  8   10 , Ewald Wöll  11 , Reinhard Ruckser  12 , Boris Bozic  12 , Maria-Theresa Krauth  13 , Andreas Petzer  14 , Clemens Schmitt  15 , Sigrid Machherndl-Spandl  16 , Hermine Agis  17 , Michael Fillitz  18 , Song-Yau Wang  19 , Stefan Knop  20 , Richard Greil  2
Affiliations

QoL during KTd or KRd induction followed by K maintenance or observation in transplant noneligible patients with newly diagnosed multiple myeloma: Longitudinal and cross-sectional analysis of the randomized AGMT 02 study

Heinz Ludwig et al. EJHaem. .

Abstract

Understanding the impact of induction and maintenance therapy on patients' quality of life (QoL) is important for treatment selection. This study aims to compare patient-reported QoL between patients treated with KTd or KRd induction therapy and K maintenance therapy or observation. QoL was assessed using the EORTC QOL-C 30 and QOL-MY20 questionnaires in the AGMT-02 study, in which 123 patients with newly diagnosed transplant ineligible multiple myeloma were randomized to nine cycles of either KTd or KRd induction therapy, followed by 12 cycles of K maintenance therapy, or observation. Longitudinal assessments showed statistically significant improvements in global health-related QoL, various disease symptoms and pain for both treatment regimens. KTd improved insomnia and fatigue, and KRd improved physical functioning. Cross-sectional comparisons indicated a "slight" superiority of KTd over KRd in several scales, with the exception of higher neuropathy scores with KTd. During maintenance, longitudinal comparisons showed no statistically significant changes. Cross-sectional comparisons revealed a "slight" improvement in cognitive functioning during carfilzomib therapy, but a worsening in most other QoL scales. Induction therapy led to improvements in most QoL items, while maintenance therapy with K maintenance was associated with "slight" or "moderate" impairments in several QoL scales compared with the observation group.

Keywords: carfilzomib; lenalidomide; multiple myeloma; quality of life; thalidomide.

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Conflict of interest statement

The study was supported by AMGEN which provided support for the conduct and analysis of the trial, and by the Austrian Forum against Cancer which supported in part the scientific assistance of HL. HL declares receiving honoraria for lectures or advisory boards from Janssen, BMS, Takeda, Pfizer, Sanofi, and Stem line and research support from AMGEN and Sanofi. TM received honoraria from AbbVie and BMS. MS received honoraria from Janssen, AbbVie, BMS, and Pfizer. BH received honoraria from BMS, Amgen, AbbVie, and Janssen‐Cilag. KP received research funding and honoraria for consultancy from Amgen, BMS, Janssen, and Roche. WW is an employee of syndena GmbH and received research funding from Amgen, Takeda, BMS‐Celgene, Janssen‐Cilag, Novartis, Roche, Sanofi, and oncotyrol and received honoraria for participation in steering and safety committees from Amgen, BMS‐Celgene, and Morphosys and received honoraria for consultancy from Amgen, Takeda, BMS‐Celgene, EUSA Pharma, Gilead, AbbVie, Janssen‐Cilag, GSK, Incyte, Kite, Novartis, Morphosys, Merck, Pfizer, Roche, Sandoz, and Sanofi, and received honoraria from Fujimoto and Myelom‐ und Lymphomselbsthilfe. MTK received research funding from Janssen and honoraria from GSK, Sanofi, Pfizer, Janssen, Amgen, BMS‐Celgene, and Takeda. AP received honoraria for participation in advisory boards from Novartis, Kite‐Gilead, Amgen, Celgene, Janssen, Roche, Sandoz, AstraZeneca, AbbVie, Takeda, Sanofi, Pfizer, Saegen, Daiichi Sankyo, and received travel support from Kite‐Gilead, Janssen, Roche, AstraZeneca, Pfizer, and Daiichi Sankyo. CS received research funding from AstraZeneca, Janssen‐Cilag, and Roche, and received honoraria for consultancy from AbbVie, AstraZeneca, BMS‐Celgene, Janssen‐Cilag, Roche, and Takeda. SMS received honoraria for consultancy from Jazz Pharmaceuticals, Novartis, Amgen, BMS, and Gilead. HA received research funding from Janssen and received honoraria from Janssen, Amgen, BMS, and Takeda. SK received honoraria from Amgen, BMS‐Celgene, and Sanofi, and received travel grants from BMS and Sobi. RG received research funding, travel support, and honoraria for consultancy and participation in advisory boards from AbbVie, Takeda, Daiichi Sankyo, Gilead, MSD Merck, BMS‐Celgene, Novartis, AstraZeneca, Janssen‐Cilag, and Hoffmann‐La Roche. The remaining authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Differences of mean EORTC QLQ‐C30 scores between baseline and each cycle of induction with KTD or KRd.
FIGURE 2
FIGURE 2
Differences of mean EORTC QLQ‐C30 scores between baseline and each cycle of maintenance with K monotherapy or observation.
See this image and copyright information in PMC

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References

    1. Landgren O, Iskander K. Modern multiple myeloma therapy: deep, sustained treatment response and good clinical outcomes. J Intern Med. 2017;281(4):365–382. - PubMed
    1. Delforge M, Shah N, Miguel JSF, Braverman J, Dhanda DS, Shi L, et al. Health‐related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma. Blood Adv. 2022;6(4):1309–1318. - PMC - PubMed
    1. Stephens RJ, Hopwood P, Girling DJ, Machin D. Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients' self‐ratings? Qual Life Res. 1997;6(3):225–236. - PubMed
    1. Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient‐reported symptoms from the Quality‐of‐Life Questionnaire C30. J. Clin. Oncol. 2004;22(17):3485–3490. - PubMed
    1. Ludwig H, Melchardt T, Sormann S, Schreder M, Andel J, Hartmann B, et al. Randomized comparison of KRd and KTd induction followed by K maintenance or observation in transplant non‐eligible patients with newly diagnosed multiple myeloma (AGMT‐MM02 Trial). Haematologica. 2024. - PubMed