Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report

Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.

Abstract

The purpose of this report is to analyze long-term clinical outcomes of patients exposed to plerixafor plus granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization. This was a study of patients with non-Hodgkin lymphoma (NHL; n = 167) and multiple myeloma (MM; n = 163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240 µg/kg plerixafor plus 10 µg/kg G-CSF, or placebo plus 10 µg/kg G-CSF to mobilize and collect CD34+ cells for autologous hematopoietic stem cell transplantation. Overall survival (OS) and progression-free survival (PFS) were evaluated over a 5-year period following the first dose of plerixafor or placebo. The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively). In addition, there was no statistically significant difference in the probability of PFS over 5 years between treatment groups in patients with NHL (50%; 95% CI, 44% to 67% for plerixafor versus 43%; 95% CI, 31% to 54% for placebo) or those with MM (17%; 95% CI, 10% to 24% for plerixafor versus 30%; 95% CI, 21% to 40% for placebo). In this long-term follow-up study, the addition of plerixafor to G-CSF for stem cell mobilization did not affect 5-year survival in patients with NHL or patients with MM.

Keywords: Long-term follow-up; Multiple myeloma; Non-Hodgkin lymphoma; Plerixafor; Stem cell mobilization.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Benzylamines
  • Child
  • Cyclams
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Hematopoietic Stem Cell Mobilization / methods
  • Hematopoietic Stem Cell Mobilization / mortality
  • Hematopoietic Stem Cell Transplantation / methods
  • Heterocyclic Compounds / therapeutic use*
  • Humans
  • Longitudinal Studies
  • Lymphoma, Non-Hodgkin / therapy*
  • Middle Aged
  • Multiple Myeloma / mortality
  • Multiple Myeloma / therapy*
  • Survival Analysis
  • Transplantation, Autologous / methods
  • Transplantation, Autologous / mortality
  • Young Adult

Substances

  • Benzylamines
  • Cyclams
  • Heterocyclic Compounds
  • Granulocyte Colony-Stimulating Factor
  • plerixafor

Associated data

  • ClinicalTrials.gov/NCT00741325
  • ClinicalTrials.gov/NCT00741780