title: Tandem Autologous Stem Cell Transplantation for Multiple Myeloma Patients Based on Response to Their First Transplant-A Prospective Phase II Study.
abstract: In this prospective phase II clinical trial, multiple myeloma (MM) patients were randomized to receive a second (tandem) autologous stem cell transplantation (ASCT) based on whether they achieved a partial response or worse (≤PR) following initial ASCT (ASCT1). Patients who achieved a very good partial response or better (≥VGPR) had salvage ASCT at relapse. Seventy-five patients received conditioning therapy and ASCT1. A total of 44 patients (59%) achieved ≥VGPR, whereas 31 patients entered ≤PR and were offered tandem ASCT. In all, 20 patients agreed to tandem ASCT. Demographic and clinical characteristics were similar between the two cohorts except for median lactate dehydrogenase (LDH) (P = 0.0141) and percentage of marrow plasma cells before ASCT1 (P = 0.0047), both lower in the ≥VGPR group. Intent to treat analysis showed that patients who achieved ≥VGPR to ASCT1 had a trend toward improved progression-free survival (PFS) (37 vs. 26 months, P = 0.078) and superior overall survival (OS) (not reached vs. 50 months, P = 0.0073). Patients with ≤PR who declined tandem transplantation had shortened PFS (20 vs. 28 months, P = 0.05) but similar OS (53 vs. 57.5 months, P = 0.29) compared to those who received it. Thus, a favorable clinical response to ASCT1 identifies a low-risk group with superior long-term prognosis despite similar PFS.
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Byrne
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Donya
authors.initials: D
authors.lastname: Salmasinia
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Helen
authors.initials: H
authors.lastname: Leather
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Cogle
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Davis
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Jack W
authors.initials: JW
authors.lastname: Hsu
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Wiggins
authors.affiliation: Department of Biostatistics, University of Florida, Gainesville, FL, USA.
authors.forename: Myron N
authors.initials: MN
authors.lastname: Chang
authors.affiliation: Department of Biostatistics, University of Florida, Gainesville, FL, USA.
authors.forename: Qi
authors.initials: Q
authors.lastname: An
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: John R
authors.initials: JR
authors.lastname: Wingard
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Jan S
authors.initials: JS
authors.lastname: Moreb
keywords: autologous stem cell transplantation; multiple myeloma; survival; tandem