Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma
Year: 2020
Type: article
Study design: Clinical Trial
Abstract: 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/m 2 ). The alloSCT reduced-intensity conditioning (RIC) regimen consisted of fludarabine (30 mg/m 2 /d i.v. on days -7 through -3) and cyclophosphamide (1 g/m 2 /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.
Institutions: University of Nebraska Medical Center, Mayo Clinic, Duke University, Duke Cancer Institute, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center, University of California, San Francisco, University of Iowa, Icahn School of Medicine at Mount Sinai, Washington University in St. Louis, MedStar Georgetown University Hospital, Roswell Park Comprehensive Cancer Center
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,650
Awards: Alliance Statistics and Data Management Center, Washington University/ Siteman Cancer Center Lead Academic Site, G2184918994, G2215807464, Network Lead Academic Participating Site Grant from the Roswell Park Cancer Institute, G3053988604, G4185274752, NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer Care, G5839345623, UNC Lead Academic Participating Site, G6105514657, NCTN Lead Academic Participating Sites Application, National Capital Area (NCA) Minority/Underserved NCORP, Alliance for Clinical Trials in Oncology Operations Center
OpenAlex ID: W3017157488