Autologous transplantation, consolidation, and maintenance therapy in multiple myeloma: Results of the BMT CTN 0702 trial

Edward A. Stadtmauer, Marcelo C. Pasquini, Beth Blackwell, Parameswaran Hari, Asad Bashey, Steven Devine, Yvonne Efebera, Siddharta Ganguly, Cristina Gasparetto, Nancy Geller, Mary M. Horowitz, John Koreth, Kristin Knust, Heather Landau, Claudio Brunstein, Philip McCarthy, Courtney Nelson, Muzaffar H. Qazilbash, Nina Shah, David H. VesoleRavi Vij, Dan T. Vogl, Sergio Giralt, George Somlo, Amrita Krishnan

Research output: Contribution to journalArticlepeer-review

75 Scopus citations

Abstract

PURPOSE Single-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression. PATIENTS AND METHODS Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS. RESULTS The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms. CONCLUSION Second AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.

Original languageEnglish (US)
Pages (from-to)589-597
Number of pages9
JournalJournal of Clinical Oncology
Volume37
Issue number7
DOIs
StatePublished - 2019

Bibliographical note

Funding Information:
Supported by Grant No. U10HL069294 to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute and the National Cancer Institute; by Celgene Corporation and Millennium (Takeda) Pharmaceuticals; and by The Alliance for Clinical Trials in Oncology, the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group, and SWOG.

Publisher Copyright:
© 2019 by American Society of Clinical Oncology.

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