Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials

Straka C, Knop S, Vogel M, Müller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Dürk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rösler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H (2019)

Publication Type: Journal article

Publication year: 2019

Journal

DOI: 10.1111/ejh.13281

Abstract

OBJECTIVE: A post hoc analysis of two phase III trials was carried out to explore the influence of age and treatment factors on the effect of bortezomib consolidation on progression-free survival (PFS) post autologous stem cell transplantation (ASCT). METHODS: Patients with newly diagnosed multiple myeloma were assigned to one of two trials (ClinicalTrials.gov IDs: NCT00416273, NCT00416208), which were conducted in parallel, based on age (18-60 or 61-75 years, respectively). Following induction and ASCT, patients were randomized 1:1 to four 35-day cycles of bortezomib consolidation (1.6 mg/m2 IV on days 1, 8, 15, 22) or observation only. RESULTS: Median PFS with bortezomib consolidation vs observation was 33.6 vs 29.0 months (P = 0.3599) in patients aged 18-60 years (n = 202), and 33.4 vs 26.4 months (P = 0.0073) in patients aged 61-75 years (n = 155), respectively. Bortezomib consolidation post-ASCT appeared to equalize outcomes between older and younger patients who received prior treatment of differing intensity. This suggests that the effect of consolidation may be relative and may depend on the composition and intensity of induction and high-dose therapy. CONCLUSION: Older patients receiving less intensive prior treatment could experience a larger PFS benefit from bortezomib consolidation.

Authors with CRIS profile

Involved external institutions

Klinikum der Universität München Germany (DE) Janssen-Cilag GmbH Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) St. Marien-Hospital Hamm Germany (DE) Otto-von-Guericke-Universität Magdeburg Germany (DE) Schwarzwald-Baar Klinikum Germany (DE) Universitätsklinikum Göttingen Germany (DE) Albert-Ludwigs-Universität Freiburg Germany (DE) Klinikum rechts der Isar Germany (DE) Universitätsklinikum Ulm Germany (DE) Asklepios Klinik Altona Germany (DE) Universitätsklinikum Jena Germany (DE) Klinikum Oldenburg Germany (DE) Universitätsklinikum Münster Germany (DE) acromion GmbH Germany (DE) Julius-Maximilians-Universität Würzburg Germany (DE) Universitätsklinikum Halle (Saale) Germany (DE)

How to cite

APA:

Straka, C., Knop, S., Vogel, M., Müller, J., Kropff, M., Metzner, B.,... Einsele, H. (2019). Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. European Journal of Haematology. https://dx.doi.org/10.1111/ejh.13281

MLA:

Straka, Christian, et al. "Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials." European Journal of Haematology (2019).

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