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A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial.

Publication ,  Journal Article
Bashir, Q; Nishihori, T; Pasquini, MC; Martens, MJ; Wu, J; Alsina, M; Anasetti, C; Brunstein, C; Dawson, P; Efebera, Y; Gasparetto, C; Hari, P ...
Published in: Transplant Cell Ther
June 2023

The role of allogeneic hematopoietic cell transplantation (allo-HCT) followed by maintenance therapy in high-risk multiple myeloma (MM) remains controversial. We evaluated the efficacy of ixazomib maintenance therapy after reduced-intensity conditioning allo-HCT from HLA-matched donors in patients with high-risk MM. The primary study endpoint was progression-free survival (PFS) postrandomization, treated as a time to event. Secondary endpoints were grade II-IV and grade II-IV acute graft-versus-host-disease (GVHD), chronic GVHD, best response, disease progression, nonrelapse mortality (NRM), overall survival (OS), toxicity, infection, and health-related quality of life. In this phase 2, double-blinded, prospective multicenter trial, we randomized patients with high-risk MM (ie, those with poor-risk cytogenetics, plasma cell leukemia, or relapsing within 24 months after autologous HCT) to ixazomib (3 mg on days 1, 8, and 15) or placebo after allo-HCT. The conditioning regimen included fludarabine/melphalan/bortezomib with tacrolimus plus methotrexate for GVHD. Fifty-seven patients were enrolled, of whom 52 (91.2%) underwent allo-HCT and 43 (82.7%) were randomized to ixazomib versus placebo. At 21 months postrandomization, the ixazomib and placebo groups had similar PFS (55.3% versus 59.1%; P = 1.00) and OS (94.7% versus 86.4%; P = .17). The cumulative incidences of grade III-IV acute GVHD at 100 days (9.5% versus 0%) and chronic GVHD at 12 months (68.6% versus 63.6%) also were similar in the 2 groups. The secondary analysis showed that at 24 months post-allo-HCT, PFS and OS were 52% and 82%, respectively, with a corresponding NRM of 11.7%. These results demonstrate the safety and durable disease control with allo-HCT in high-risk MM patients. We could not adequately assess the efficacy of ixazomib maintenance because the trial terminated early owing to enrollment delays, but there was no indication of any impact on outcomes.

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Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

June 2023

Volume

29

Issue

6

Start / End Page

358.e1 / 358.e7

Location

United States

Related Subject Headings

  • Transplantation, Homologous
  • Quality of Life
  • Prospective Studies
  • Multiple Myeloma
  • Immunology
  • Humans
  • Graft vs Host Disease
  • Bone Marrow
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Bashir, Q., Nishihori, T., Pasquini, M. C., Martens, M. J., Wu, J., Alsina, M., … Hari, P. (2023). A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial. Transplant Cell Ther, 29(6), 358.e1-358.e7. https://doi.org/10.1016/j.jtct.2022.07.007
Bashir, Qaiser, Taiga Nishihori, Marcelo C. Pasquini, Michael J. Martens, Juan Wu, Melissa Alsina, Claudio Anasetti, et al. “A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial.Transplant Cell Ther 29, no. 6 (June 2023): 358.e1-358.e7. https://doi.org/10.1016/j.jtct.2022.07.007.
Bashir Q, Nishihori T, Pasquini MC, Martens MJ, Wu J, Alsina M, Anasetti C, Brunstein C, Dawson P, Efebera Y, Gasparetto C, Geller N, Giralt S, Hall AC, Koreth J, McCarthy P, Scott E, Stadtmauer EA, Vesole DH, Hari P. A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial. Transplant Cell Ther. 2023 Jun;29(6):358.e1-358.e7.

Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

June 2023

Volume

29

Issue

6

Start / End Page

358.e1 / 358.e7

Location

United States

Related Subject Headings

  • Transplantation, Homologous
  • Quality of Life
  • Prospective Studies
  • Multiple Myeloma
  • Immunology
  • Humans
  • Graft vs Host Disease
  • Bone Marrow
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences