BACKGROUND: High-dose therapy with supporting autologous stem-cell transplantation remains a controversial treatment for cancer. In multiple myeloma, first-line regimens incorporating high-dose therapy yield higher remission rates than do conventional-dose treatments, but evidence that this translates into improved survival is limited. METHODS: In this multicenter study, the Medical Research Council Myeloma VII Trial, we randomly assigned 407 patients with previously untreated multiple myeloma who were younger than 65 years of age to receive eitherstandard conventional-dose combination chemotherapy or high-dose therapy and an autologous stem-cell transplant. RESULTS: Among the 401 patients who could be evaluated, the rates of complete response were higher in the intensive-therapy group than in the standard-therapy group (44 percent vs. 8 percent, P<0.001). The rates of partial response were similar (42 percent and 40 percent, respectively; P=0.72), and the rates of minimal response were lower in the intensive-therapy group than in the standard-therapy group (3 percent vs. 18 percent, P<0.001). Intention-to-treat analysis showed a higher rate of overall survival (P=0.04 by the log-rank test) and progression-free survival (P<0.001) in the intensive-therapy group than in the standard-therapy group. As compared with standard therapy, intensive treatment increased median survival by almost 1 year (54.1 months [95 percent confidence interval, 44.9 to 65.2] vs. 42.3 months [95 percent confidence interval, 33.1 to 51.6]). There was a trend toward a greater survival benefit in the group of patients with a poor prognosis, as defined by a high beta2-microglobulin level (more than 8 mg per liter). CONCLUSIONS: High-dose therapy with autologous stem-cell rescue is an effective first-line treatment for patients with multiple myeloma who are younger than 65 years of age. Copyright 2003 Massachusetts Medical Society
RCT Entities:
BACKGROUND: High-dose therapy with supporting autologous stem-cell transplantation remains a controversial treatment for cancer. In multiple myeloma, first-line regimens incorporating high-dose therapy yield higher remission rates than do conventional-dose treatments, but evidence that this translates into improved survival is limited. METHODS: In this multicenter study, the Medical Research Council Myeloma VII Trial, we randomly assigned 407 patients with previously untreated multiple myeloma who were younger than 65 years of age to receive either standard conventional-dose combination chemotherapy or high-dose therapy and an autologous stem-cell transplant. RESULTS: Among the 401 patients who could be evaluated, the rates of complete response were higher in the intensive-therapy group than in the standard-therapy group (44 percent vs. 8 percent, P<0.001). The rates of partial response were similar (42 percent and 40 percent, respectively; P=0.72), and the rates of minimal response were lower in the intensive-therapy group than in the standard-therapy group (3 percent vs. 18 percent, P<0.001). Intention-to-treat analysis showed a higher rate of overall survival (P=0.04 by the log-rank test) and progression-free survival (P<0.001) in the intensive-therapy group than in the standard-therapy group. As compared with standard therapy, intensive treatment increased median survival by almost 1 year (54.1 months [95 percent confidence interval, 44.9 to 65.2] vs. 42.3 months [95 percent confidence interval, 33.1 to 51.6]). There was a trend toward a greater survival benefit in the group of patients with a poor prognosis, as defined by a high beta2-microglobulin level (more than 8 mg per liter). CONCLUSIONS: High-dose therapy with autologous stem-cell rescue is an effective first-line treatment for patients with multiple myeloma who are younger than 65 years of age. Copyright 2003 Massachusetts Medical Society
Authors: A Dispenzieri; A D'Souza; M A Gertz; K Laumann; G Wiseman; M Q Lacy; B LaPlant; F Buadi; S R Hayman; S K Kumar; D Dingli; W J Hogan; S M Ansell; D A Gastineau; D J Inwards; I N Micallef; L F Porrata; P B Johnston; M R Litzow; T E Witzig Journal: Bone Marrow Transplant Date: 2017-09-04 Impact factor: 5.483
Authors: Christian Straka; Peter Liebisch; Hans Salwender; Burkhard Hennemann; Bernd Metzner; Stefan Knop; Sigrid Adler-Reichel; Christian Gerecke; Hannes Wandt; Martin Bentz; Tim Hendrik Bruemmendorf; Marcus Hentrich; Michael Pfreundschuh; Hans-Heinrich Wolf; Orhan Sezer; Ralf Bargou; Wolfram Jung; Lorenz Trümper; Bernd Hertenstein; Else Heidemann; Helga Bernhard; Nicola Lang; Norbert Frickhofen; Holger Hebart; Ralf Schmidmaier; Andreas Sandermann; Tobias Dechow; Albrecht Reichle; Brigitte Schnabel; Kerstin Schäfer-Eckart; Christian Langer; Martin Gramatzki; Axel Hinke; Bertold Emmerich; Hermann Einsele Journal: Haematologica Date: 2016-08-04 Impact factor: 9.941