Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial

Single-cycle melphalan 200 mg/m 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, ran...

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Veröffentlicht in:Journal of clinical oncology Jg. 37; H. 7; S. 589
Hauptverfasser: Stadtmauer, Edward A, Pasquini, Marcelo C, Blackwell, Beth, Hari, Parameswaran, Bashey, Asad, Devine, Steven, Efebera, Yvonne, Ganguly, Siddharta, Gasparetto, Cristina, Geller, Nancy, Horowitz, Mary M, Koreth, John, Knust, Kristin, Landau, Heather, Brunstein, Claudio, McCarthy, Philip, Nelson, Courtney, Qazilbash, Muzaffar H, Shah, Nina, Vesole, David H, Vij, Ravi, Vogl, Dan T, Giralt, Sergio, Somlo, George, Krishnan, Amrita
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.03.2019
Schlagworte:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Bortezomib - administration & dosage
Bortezomib - adverse effects
Consolidation Chemotherapy
Dexamethasone - administration & dosage
Dexamethasone - adverse effects
Disease Progression
Female
Hematopoietic Stem Cell Transplantation - adverse effects
Hematopoietic Stem Cell Transplantation - mortality
Humans
Lenalidomide - administration & dosage
Lenalidomide - adverse effects
Maintenance Chemotherapy
Male
Melphalan - administration & dosage
Middle Aged
Multiple Myeloma - mortality
Multiple Myeloma - pathology
Multiple Myeloma - therapy
Myeloablative Agonists - administration & dosage
Progression-Free Survival
Prospective Studies
Remission Induction
Reoperation
Time Factors
Transplantation, Autologous
United States
Young Adult
United States
ISSN:1527-7755, 1527-7755
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Zusammenfassung:Single-cycle melphalan 200 mg/m 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 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. 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. 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.
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.18.00685