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Journal of Cancer Research and Clinical Oncology

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21.08.2017 | Original Article – Clinical Oncology

Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077)

verfasst von: Juliane Beck, Andreas Schwarzer, Dietrich Gläser, Lars-Olof Mügge, Jens Uhlig, Simone Heyn, Brigitte Kragl, Martin Mohren, Franz Albert Hoffmann, Thoralf Lange, Thomas Schliwa, Thomas Zehrfeld, Cornelia Becker, Ute Kreibich, Cornelia Winkelmann, Thomas Edelmann, Marc Andrea, Marius Bill, Madlen Jentzsch, Sebastian Schwind, Dietger Niederwieser, Wolfram Pönisch

Erschienen in: Journal of Cancer Research and Clinical Oncology | Ausgabe 12/2017

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Abstract

Introduction

While lenalidomide monotherapy is established for relapsed and/or refractory multiple myeloma (MM) treatment, combination therapies including lenalidomide are still under investigation in a number of phase 2/3 studies. In the current study, a treatment regime of lenalidomide (Revlimid^®), bendamustine and prednisolone (RBP) was tested in patients with relapsed/refractory MM.

Methods

In the previously completed phase 1 study RBP with a dose of 75 mg/m² bendamustine days 1–2, prednisolone 100 mg days 1–4 and 25 mg lenalidomide days 1–21 was well tolerated.

Results

Between July 2011 and September 2013, 25 patients were included in this analysis. The median number of previous treatments was 1 (range 1–2). Twenty-two patients (88%) responded after at least two cycles of RBP (one sCR, five nCR, eight VGPR and eight PR). The median time to first haematological response was 28 days, and median time to best response was 56 days. Due to increased haematological toxicity a dose reduction in most patients required in subsequent cycles of therapy. The median progression-free and overall survival was 22 and 38 months, respectively.

Summary

In conclusion RBP is a highly effective therapy for patients with relapsed/refractory MM. In contrast to our phase 1 study, dose reduction was necessary in many patients because of haematological toxicity.

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Titel: Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077)
verfasst von: Juliane Beck
Andreas Schwarzer
Dietrich Gläser
Lars-Olof Mügge
Jens Uhlig
Simone Heyn
Brigitte Kragl
Martin Mohren
Franz Albert Hoffmann
Thoralf Lange
Thomas Schliwa
Thomas Zehrfeld
Cornelia Becker
Ute Kreibich
Cornelia Winkelmann
Thomas Edelmann
Marc Andrea
Marius Bill
Madlen Jentzsch
Sebastian Schwind
Dietger Niederwieser
Wolfram Pönisch
Publikationsdatum: 21.08.2017
Verlag: Springer Berlin Heidelberg
Erschienen in: Journal of Cancer Research and Clinical Oncology / Ausgabe 12/2017
Print ISSN: 0171-5216
Elektronische ISSN: 1432-1335
DOI: https://doi.org/10.1007/s00432-017-2504-5

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Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077)