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

Publication ,  Journal Article
Stadtmauer, EA; Pasquini, MC; Blackwell, B; Hari, P; Bashey, A; Devine, S; Efebera, Y; Ganguly, S; Gasparetto, C; Geller, N; Horowitz, MM ...
Published in: J Clin Oncol
March 1, 2019

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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 1, 2019

Volume

37

Issue

7

Start / End Page

589 / 597

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Transplantation, Autologous
  • Time Factors
  • Reoperation
  • Remission Induction
  • Prospective Studies
  • Progression-Free Survival
  • Oncology & Carcinogenesis
  • Myeloablative Agonists
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Stadtmauer, E. A., Pasquini, M. C., Blackwell, B., Hari, P., Bashey, A., Devine, S., … Krishnan, A. (2019). Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol, 37(7), 589–597. https://doi.org/10.1200/JCO.18.00685
Stadtmauer, Edward A., Marcelo C. Pasquini, Beth Blackwell, Parameswaran Hari, Asad Bashey, Steven Devine, Yvonne Efebera, et al. “Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial.J Clin Oncol 37, no. 7 (March 1, 2019): 589–97. https://doi.org/10.1200/JCO.18.00685.
Stadtmauer EA, Pasquini MC, Blackwell B, Hari P, Bashey A, Devine S, et al. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol. 2019 Mar 1;37(7):589–97.
Stadtmauer, Edward A., et al. “Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial.J Clin Oncol, vol. 37, no. 7, Mar. 2019, pp. 589–97. Pubmed, doi:10.1200/JCO.18.00685.
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. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol. 2019 Mar 1;37(7):589–597.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 1, 2019

Volume

37

Issue

7

Start / End Page

589 / 597

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Transplantation, Autologous
  • Time Factors
  • Reoperation
  • Remission Induction
  • Prospective Studies
  • Progression-Free Survival
  • Oncology & Carcinogenesis
  • Myeloablative Agonists