|Title||Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Stadtmauer, EA, Pasquini, MC, Blackwell, B, Hari, P, Bashey, A, Devine, S, Efebera, Y, Ganguly, S, Gasparetto, C, Geller, N, Horowitz, MM, Koreth, J, Knust, K, Landau, H, Brunstein, C, McCarthy, P, Nelson, C, Qazilbash, MH, Shah, N, Vesole, DH, Vij, R, Vogl, DT, Giralt, S, Somlo, G, Krishnan, A|
|Journal||J Clin Oncol|
|Date Published||2019 03 01|
|Keywords||Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Consolidation Chemotherapy, Dexamethasone, Disease Progression, Female, Hematopoietic Stem Cell Transplantation, Humans, Lenalidomide, Maintenance Chemotherapy, Male, Melphalan, Middle Aged, Multiple Myeloma, Myeloablative Agonists, Progression-Free Survival, Prospective Studies, Remission Induction, Reoperation, Time Factors, Transplantation, Autologous, United States, Young Adult|
PURPOSE: 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 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.
|Alternate Journal||J Clin Oncol|
|PubMed Central ID||PMC6553842|
|Grant List||U10 HL069294 / HL / NHLBI NIH HHS / United States |
P30 CA016672 / CA / NCI NIH HHS / United States
UG1 HL069286 / HL / NHLBI NIH HHS / United States
UG1 HL069290 / HL / NHLBI NIH HHS / United States
P30 CA077598 / CA / NCI NIH HHS / United States
UG1 HL069278 / HL / NHLBI NIH HHS / United States
UG1 HL069246 / HL / NHLBI NIH HHS / United States
U10 HL069274 / HL / NHLBI NIH HHS / United States
UG1 HL069249 / HL / NHLBI NIH HHS / United States
U24 CA076518 / CA / NCI NIH HHS / United States
U24 HL138660 / HL / NHLBI NIH HHS / United States
P30 CA008748 / CA / NCI NIH HHS / United States
UG1 HL109137 / HL / NHLBI NIH HHS / United States