BACKGROUND: In multiple myeloma, combination chemotherapy with melphalan plus prednisone is still regarded as the standard of care in elderly patients. We assessed whether the addition of thalidomide to this combination, or reduced-intensity stem cell transplantation, would improve survival. METHODS:Between May 22, 2000, and Aug 8, 2005, 447 previously untreated patients with multiple myeloma, who were aged between 65 and 75 years, were randomly assigned to receive either melphalan and prednisone (MP; n=196), melphalan and prednisone plus thalidomide (MPT; n=125), or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 (MEL100; n=126). The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00367185. FINDINGS: After a median follow-up of 51.5 months (IQR 34.4-63.2), median overall survival times were 33.2 months (13.8-54.8) for MP, 51.6 months (26.6-not reached) for MPT, and 38.3 months (13.0-61.6) for MEL100. The MPT regimen was associated with a significantly better overall survival than was the MP regimen (hazard ratio 0.59, 95% CI 0.46-0.81, p=0.0006) or MEL100 regimen (0.69, 0.49-0.96, p=0.027). No difference was seen for MEL100 versus MP (0.86, 0.65-1.15, p=0.32). INTERPRETATION: The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should, at present, be the reference treatment for previously untreated elderly patients with multiple myeloma.
RCT Entities:
BACKGROUND: In multiple myeloma, combination chemotherapy with melphalan plus prednisone is still regarded as the standard of care in elderly patients. We assessed whether the addition of thalidomide to this combination, or reduced-intensity stem cell transplantation, would improve survival. METHODS: Between May 22, 2000, and Aug 8, 2005, 447 previously untreated patients with multiple myeloma, who were aged between 65 and 75 years, were randomly assigned to receive either melphalan and prednisone (MP; n=196), melphalan and prednisone plus thalidomide (MPT; n=125), or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 (MEL100; n=126). The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00367185. FINDINGS: After a median follow-up of 51.5 months (IQR 34.4-63.2), median overall survival times were 33.2 months (13.8-54.8) for MP, 51.6 months (26.6-not reached) for MPT, and 38.3 months (13.0-61.6) for MEL100. The MPT regimen was associated with a significantly better overall survival than was the MP regimen (hazard ratio 0.59, 95% CI 0.46-0.81, p=0.0006) or MEL100 regimen (0.69, 0.49-0.96, p=0.027). No difference was seen for MEL100 versus MP (0.86, 0.65-1.15, p=0.32). INTERPRETATION: The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should, at present, be the reference treatment for previously untreated elderly patients with multiple myeloma.
Authors: Shaji K Kumar; Martha Q Lacy; Suzanne R Hayman; Keith Stewart; Francis K Buadi; Jacob Allred; Kristina Laumann; Philip R Greipp; John A Lust; Morie A Gertz; Steven R Zeldenrust; P Leif Bergsagel; Craig B Reeder; Thomas E Witzig; Rafael Fonseca; Stephen J Russell; Joseph R Mikhael; David Dingli; S Vincent Rajkumar; Angela Dispenzieri Journal: Am J Hematol Date: 2011-05-31 Impact factor: 10.047
Authors: Arti Hurria; Ilene S Browner; Harvey Jay Cohen; Crystal S Denlinger; Mollie deShazo; Martine Extermann; Apar Kishor P Ganti; Jimmie C Holland; Holly M Holmes; Mohana B Karlekar; Nancy L Keating; June McKoy; Bruno C Medeiros; Ewa Mrozek; Tracey O'Connor; Stephen H Petersdorf; Hope S Rugo; Rebecca A Silliman; William P Tew; Louise C Walter; Alva B Weir; Tanya Wildes Journal: J Natl Compr Canc Netw Date: 2012-02 Impact factor: 11.908
Authors: Carlos Fernández de Larrea; Natalia Tovar; M Teresa Cibeira; Juan I Aróstegui; Laura Rosiñol; Montserrat Elena; Xavier Filella; Jordi Yagüe; Joan Bladé Journal: Haematologica Date: 2010-09-30 Impact factor: 9.941
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