Universität zu Köln

Richardson, Tim ORCID: 0009-0006-3588-6376, Mai, Elias ORCID: 0000-0002-6226-1252, Menis, Ekaterina ORCID: 0000-0002-5539-580X, Benner, Axel ORCID: 0000-0002-7238-6956, Tichy, Diana, Miah, Kaya ORCID: 0000-0002-0265-3529, Hänel, Mathias ORCID: 0000-0002-4767-3275, Besemer, Britta, Boquoi, Amelie, Blau, Igor Wolfgang, Michel, Christian S. ORCID: 0009-0004-1596-3763, Lindemann, Hans Walter ORCID: 0000-0001-9836-7932, Janjetovic, Snjezana, Brossart, Peter ORCID: 0000-0001-5133-1094, Bernhard, Helga, Reimer, Peter, Salwender, Hans ORCID: 0000-0001-7803-0814, Hose, Dirk, Seckinger, Anja, Raab, Marc, Goldschmidt, Hartmut ORCID: 0000-0003-0961-0035 and Scheid, Christof ORCID: 0009-0007-6539-226X (2026). Prognostic Impact of the Hevylite Assay in Patients With IgG or IgA Multiple Myeloma Treated Within the GMMG ‐ MM5 Trial. European Journal of Haematology, 116 (3). pp. 226-234. Wiley. ISSN 0902-4441

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Abstract

Response assessment during treatment of multiple myeloma (MM) typically relies on immunofixation and serum electrophoresis. However, low levels of IgG and especially IgA paraprotein are difficult to quantify reliably. The Hevylite Assay quantifies the kappa and lambda fractions of IgG and IgA separately and is useful to determine response to therapy. Using serum samples of 360 evaluable patients from the prospective GMMG‐MM5 trial (EudraCT‐No. 2010–019173‐16) we assessed the normalization of the kappa/lambda ratio with the Hevylite Assay (HLCr) at baseline, after induction, mobilization, autologous blood stem cell transplantation, consolidation and every three months during maintenance or follow‐up within two years after the end of consolidation. We observed a steady increase in the proportion of patients with normalized HLCr over the course of therapyAchieving HLCr normalization any time until the end of consolidation was associated with a trend towards a prolonged progression‐free survival (PFS; hazard ratio (HR) = 0.75, 95% confidence interval (95% CI) = 0.56–1.01, p = 0.06) but not overall survival (OS; HR = 0.94, 95% CI = 0.69–1.26, p = 0.66) in multivariable time‐dependent Cox regression analyses. Using a landmark analysis from the end of consolidation there was again a marginally statistically significant effect of HLCr normalization by the end of consolidation on PFS using a multivariable Cox model on the subset of the two study arms with continuous lenalidomide maintenance (HR 0.61, 95% CI 0.37–1.02, p = 0.06). No such effect was observed in study arms in which maintenance was only applied to patients not in CR at the end of consolidation. In conclusion, our analysis of the Hevylite Assay in patients with IgG or IgA myeloma from the GMMG‐MM5 study did not find evidence to support the general use of HLCr normalization as a response parameter for predicting PFS or OS. However, the differential effects of HLCr normalization depending on the way in which treatment was adapted to response may be of interest for future study designs on response‐adapted therapy. Trial Registration: ISRCTN05622749.

Item Type:	Article
Creators:	Creators Email ORCID ORCID Put Code Richardson, Tim UNSPECIFIED https://orcid.org/0009-0006-3588-6376 UNSPECIFIED Mai, Elias UNSPECIFIED https://orcid.org/0000-0002-6226-1252 UNSPECIFIED Menis, Ekaterina UNSPECIFIED https://orcid.org/0000-0002-5539-580X UNSPECIFIED Benner, Axel UNSPECIFIED https://orcid.org/0000-0002-7238-6956 UNSPECIFIED Tichy, Diana UNSPECIFIED UNSPECIFIED UNSPECIFIED Miah, Kaya UNSPECIFIED https://orcid.org/0000-0002-0265-3529 UNSPECIFIED Hänel, Mathias UNSPECIFIED https://orcid.org/0000-0002-4767-3275 UNSPECIFIED Besemer, Britta UNSPECIFIED UNSPECIFIED UNSPECIFIED Boquoi, Amelie UNSPECIFIED UNSPECIFIED UNSPECIFIED Blau, Igor Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Michel, Christian S. UNSPECIFIED https://orcid.org/0009-0004-1596-3763 UNSPECIFIED Lindemann, Hans Walter UNSPECIFIED https://orcid.org/0000-0001-9836-7932 UNSPECIFIED Janjetovic, Snjezana UNSPECIFIED UNSPECIFIED UNSPECIFIED Brossart, Peter UNSPECIFIED https://orcid.org/0000-0001-5133-1094 UNSPECIFIED Bernhard, Helga UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Salwender, Hans UNSPECIFIED https://orcid.org/0000-0001-7803-0814 UNSPECIFIED Hose, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Seckinger, Anja UNSPECIFIED UNSPECIFIED UNSPECIFIED Raab, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Goldschmidt, Hartmut UNSPECIFIED https://orcid.org/0000-0003-0961-0035 UNSPECIFIED Scheid, Christof UNSPECIFIED https://orcid.org/0009-0007-6539-226X UNSPECIFIED
URN:	urn:nbn:de:hbz:38-803461
Identification Number:	10.1111/ejh.70061
Journal or Publication Title:	European Journal of Haematology
Volume:	116
Number:	3
Page Range:	pp. 226-234
Number of Pages:	9
Date:	11 March 2026
Publisher:	Wiley
ISSN:	0902-4441
Language:	English
Faculty:	Faculty of Medicine
Divisions:	Faculty of Medicine > Innere Medizin > Klinik I für Innere Medizin - Hämatologie und Onkologie
Subjects:	Medical sciences Medicine
Uncontrolled Keywords:	Keywords Language heavylite assay ; multiple myeloma ; prognostic biomarker English
['eprint_fieldname_oa_funders' not defined]:	Publikationsfonds UzK
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/80346