Farag, Sarah; Bacher, Ulrike; Jeker, Barbara; Legros, Myriam; Rhyner, Gaelle; Lüthi, Jean-Marc; Schardt, Julian; Zander, Thilo; Daskalakis, Michael; Mansouri, Behrouz; Manz, Chantal; Pabst, Thomas (2022). Adding bendamustine to melphalan before ASCT improves CR rate in myeloma vs. melphalan alone: A randomized phase-2 trial. Bone marrow transplantation, 57(6), pp. 990-997. Springer Nature 10.1038/s41409-022-01681-y
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Definite cure remains exceptional in myeloma patients even after high-dose chemotherapy (HDCT) with melphalan (Mel) and autologous stem cell transplantation (ASCT). Thus, improving efficacy of HDCT in MM remains an unresolved issue. This randomized phase II trial compared standard 200 mg/m2 Mel HDCT to experimental HDCT with 200 mg/m2 bendamustine, given both at days -4 and -3, combined with 100 mg/m2 melphalan at days -2 and -1 (BenMel) before ASCT as first-line consolidation in myeloma patients. The primary endpoint aimed to identify at least a 15% improvement in the complete remission rate (stringent CR + CR) after HDCT with BenMel compared with Mel alone. A total of 120 MM patients were 1:1 randomized. The rate of sCR/CR after ASCT was higher in BenMel than in Mel treated patients (70.0% vs. 51.7%; p = 0.039). Three patients in the BenMel group (5.0%) had reversible acute renal insufficiency compared with none in Mel patients. Minimal residual disease negativity (<10-5) by flow cytometry was observed in 26 (45.6%) BenMel patients and 22 (37.9%) in the Mel group (p = 0.375). Our data suggest that BenMel HDCT is safe and improves the sCR/CR rate compared with standard Mel alone.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology 04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory |
UniBE Contributor: |
Farag, Sarah Ahmed Ibrahim, Bacher, Vera Ulrike, Jeker, Barbara, Legros, Myriam, Daskalakis, Michael, Mansouri Taleghani, Behrouz, Pabst, Thomas Niklaus |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1476-5365 |
Publisher: |
Springer Nature |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
22 Apr 2022 11:36 |
Last Modified: |
05 Dec 2022 16:19 |
Publisher DOI: |
10.1038/s41409-022-01681-y |
PubMed ID: |
35444232 |
BORIS DOI: |
10.48350/169441 |
URI: |
https://boris.unibe.ch/id/eprint/169441 |
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