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Outcomes in newly diagnosed young or high-risk myeloma patients receiving tandem autologous/allogeneic transplant followed by bortezomib maintenance: a phase II study

Bone Marrow Transplantation volume 57, pages 252–260 (2022)Cite this article

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Abstract

Despite novel drugs and autologous HCT, MM remains incurable, with short survival in patients with poor biological characteristics. Allo HCT may be curative in some patients but is hampered by high rates of toxicity and relapse. We hypothesized that bortezomib (BTZ), with its anti-myeloma and immunologic properties, could improve PFS and cGVHD after allo HCT in newly diagnosed MM patients. In this prospective phase II study, we included 39 young (≤50 years) and high-risk patients who received a tandem auto-allo HCT followed by BTZ. Patients had prospective minimal residual disease (MRD) evaluations using Next-Generation Flow cytometry prior to allo HCT, prior BTZ and every 3 months for 2 years. With a median follow-up of 48 months, we report PFS and OS at 5 years of 41% and 80%, with a non-relapse mortality of 12%. Incidences of grade II-IV aGVHD at 12 months and moderate/severe cGVHD at 2 years were 26% and 57%. In a multivariate analysis model including cytogenetics, ISS and MRD status, MRD positivity prior to allo HCT (HR 3.75, p = 0.037), prior BTZ (HR 11.3, p = 0.018) and 3 months post-BTZ initiation (HR 9.7, p = 0.001) was highly predictive of progression. Peritransplant MRD assessment thus strongly predicts disease progression.

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Fig. 1: Consort diagram of enrolled patients.
Fig. 2: Survival after allogeneic transplant.
Fig. 3: Multivariate analyses of incidence of progression based on bone marrow minimal residual disease.
Fig. 4: Incidences of chronic graft-versus-host disease.
Fig. 5: Quality of life global scores.

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Acknowledgements

We wish to thank HMR oncology pharmacy for providing bortezomib free of charge, Mrs. Myriam Hébert, Nathalie Lachapelle and Catherine Paquin for patients’ supervision and Mrs. Mélissa Fournier-Martinez, Yu Lin Luo and Johanne Blais for data collection.

Funding

This work was supported by the Myeloma Canada Chair of Université de Montréal and the Maryse and William Brock Chair in Applied Research into Stem Cell Transplantation.

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Authors and Affiliations

  1. Division of Hematology, Oncology and Transplantation, Hôpital Maisonneuve-Rosemont, Department of Medicine/Université de Montréal, Montreal, QC, Canada

    Richard LeBlanc, Imran Ahmad, Jean-Sébastien Delisle, Nadia Bambace, Léa Bernard, Sandra Cohen, Thomas Kiss, Silvy Lachance, Guy Sauvageau, Denis Claude Roy & Jean Roy

  2. Division of Hematology, Oncology and Transplantation, Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada

    Rafik Terra & Séverine Landais

  3. Division of Hematology and Oncology, Hôpital du Sacré-Coeur, Department of Medicine/Université de Montréal, Montreal, QC, Canada

    Jean-Samuel Boudreault

  4. Chronic Pain Clinic, Hôpital Maisonneuve-Rosemont, Department of Anesthesiology and Pain Medicine/Université de Montréal, Montreal, QC, Canada

    David Ogez

  5. Laboratoire de psychopathologie et processus de santé, Université de Paris, Paris, Boulogne-Billancourt, France

    Kristopher Lamore

  6. Division of Hematology and Oncology, Centre Hospitalier de l’Université de Montréal, Department of Medicine/Université de Montréal, Montreal, QC, Canada

    Émilie Lemieux-Blanchard

  7. Division of Hematology, McGill University Health Center, Department of Medicine/McGill University, Montreal, QC, Canada

    Michael Sebag

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  1. Richard LeBlanc
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Contributions

RL and IA conceived and planned the clinical trial, wrote the protocol, acquired data, analyzed the data, wrote the manuscript (including first version). IA performed the statistics. RT performed the analysis and interpretation on minimal residual disease assessment, wrote the section on minimal residual disease and revised the manuscript. JSBP contributed to patient enrollment, revised the manuscript. DO analyzed the data on quality of life, wrote the section on quality of life and revised the manuscript. KL analyzed the data on quality of life, wrote the section on quality of life and revised the manuscript. JSD acquired data, revised the manuscript. NB acquired data, revised the manuscript. LB acquired data, revised the manuscript. SC, TK, SLan, DCR acquired data, revised the manuscript. SLan coordinated the clinical trial. ÉLB contributed to patient enrollment, revised the manuscript. GS acquired data, analyzed the data, revised the manuscript. MS contributed to patient enrollment, revised the manuscript. JR conceived and planned the clinical trial, wrote the protocol, acquired data, analyzed the data, wrote the manuscript (including first version).

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Correspondence to Richard LeBlanc.

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Competing interests

RL: consultancy for Bristol Myers Squibb/Celgene, Janssen, Amgen, Sanofi and Takeda; research funding as a co-investigator from BMS/Celgene. IA: consultancy for Novartis; research funding from Sanofi Genzyme. JSBP: consultancy for Bristol Myers Squibb/Celgene, Janssen and Amgen. SC: consultancy for ExCellThera Inc; potential royalties from ExCellThera Inc. SLac: consultancy for Novartis and Jazz Pharmaceuticals Canada; potential royalties from ExCellThera Inc. ÉLB: consultancy for Bristol Myers Squibb/Celgene and Janssen. GS: employment: CEO - ExCellThera Inc, consultancy for Bristol Myers Squibb, ownership interest in a start-up company for ExCellThera, research funding from ExCellThera Inc, Royalties from ExCellThera Inc. MS: consultancy for Bristol Myers Squibb/Celgene, Janssen, Amgen, Takeda. DCR: consultancy for Kiadis Pharma. JR: consultancy for Bristol Myers Squibb/Celgene, Janssen, Amgen, Sanofi and Takeda; research funding as a principal investigator from BMS/Celgene; potential royalties from ExCellThera Inc. RT, DO, KL, JSD, NB, LB, TK, SLan: no conflict of interests.

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LeBlanc, R., Ahmad, I., Terra, R. et al. Outcomes in newly diagnosed young or high-risk myeloma patients receiving tandem autologous/allogeneic transplant followed by bortezomib maintenance: a phase II study. Bone Marrow Transplant 57, 252–260 (2022). https://doi.org/10.1038/s41409-021-01532-2

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