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Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma.

Publication ,  Journal Article
Holstein, SA; Suman, VJ; Owzar, K; Santo, K; Benson, DM; Shea, TC; Martin, T; Silverman, M; Isola, L; Vij, R; Cheson, BD; Linker, C ...
Published in: Biol Blood Marrow Transplant
August 2020

CALGB (Alliance) 100001 was a phase II study evaluating autologous stem cell transplant (ASCT) followed by nonmyeloablative allogeneic stem cell transplant (alloSCT) in patients with multiple myeloma who had received no more than 18 months of prior therapy and had experienced no more than 1 prior progression event. Conditioning for ASCT was with high-dose melphalan (200 mg/m2). The alloSCT reduced-intensity conditioning (RIC) regimen consisted of fludarabine (30 mg/m2/d i.v. on days -7 through -3) and cyclophosphamide (1 g/m2/d i.v. on days -4 through -3). The primary objective was to determine the 6-month post-alloSCT treatment-related mortality (TRM) rate. Additional objectives included determining the proportion of patients who could complete this tandem ASCT-alloSCT approach in a cooperative group setting, overall response rates, rates of donor chimerism, rates of graft-versus-host disease (GVHD), disease-free survival, and overall survival (OS). Sixty patients were enrolled, of whom 57 (95%) completed ASCT and 49 (82%) completed tandem ASCT-alloSCT. The TRM rate was 2% (1/49; 90% confidence interval, 0.10% to 9.3%). Moderate to severe (grades 2 to 3) acute GVHD was observed in 13 of 49 alloSCT patients (27%). One patient died due to GVHD within 9 months of alloSCT. Twenty-seven of the 49 patients (55%) who underwent alloSCT reported chronic GVHD as either limited (15/49; 31%) or extensive (12/49; 24%) in the first year post-alloSCT and prior to the start of nonprotocol therapy for progressive disease. With a median follow-up for survival of 11 years, the median OS time is 6.6 years and the median time to disease progression is 3.6 years. Similar to other studies, this study confirmed that tandem ASCT/alloSCT is associated with durable disease control in a subset of patients. This study demonstrated the feasibility of performing tandem ASCT/alloSCT in a cooperative group setting and determined that a fludarabine/cyclophosphamide RIC regimen is associated with a very low TRM rate.

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Published In

Biol Blood Marrow Transplant

DOI

EISSN

1523-6536

Publication Date

August 2020

Volume

26

Issue

8

Start / End Page

1414 / 1424

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Transplantation, Autologous
  • Transplantation Conditioning
  • Multiple Myeloma
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Follow-Up Studies
 

Citation

APA
Chicago
ICMJE
MLA
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Holstein, S. A., Suman, V. J., Owzar, K., Santo, K., Benson, D. M., Shea, T. C., … McCarthy, P. L. (2020). Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant, 26(8), 1414–1424. https://doi.org/10.1016/j.bbmt.2020.03.028
Holstein, Sarah A., Vera J. Suman, Kouros Owzar, Katelyn Santo, Don M. Benson, Thomas C. Shea, Thomas Martin, et al. “Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma.Biol Blood Marrow Transplant 26, no. 8 (August 2020): 1414–24. https://doi.org/10.1016/j.bbmt.2020.03.028.
Holstein SA, Suman VJ, Owzar K, Santo K, Benson DM, Shea TC, et al. Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant. 2020 Aug;26(8):1414–24.
Holstein, Sarah A., et al. “Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma.Biol Blood Marrow Transplant, vol. 26, no. 8, Aug. 2020, pp. 1414–24. Pubmed, doi:10.1016/j.bbmt.2020.03.028.
Holstein SA, Suman VJ, Owzar K, Santo K, Benson DM, Shea TC, Martin T, Silverman M, Isola L, Vij R, Cheson BD, Linker C, Anderson KC, Richardson PG, McCarthy PL. Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant. 2020 Aug;26(8):1414–1424.
Journal cover image

Published In

Biol Blood Marrow Transplant

DOI

EISSN

1523-6536

Publication Date

August 2020

Volume

26

Issue

8

Start / End Page

1414 / 1424

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Transplantation, Autologous
  • Transplantation Conditioning
  • Multiple Myeloma
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Follow-Up Studies