PMID- 20048187 OWN - NLM STAT- MEDLINE DCOM- 20100304 LR - 20201215 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 28 IP - 5 DP - 2010 Feb 10 TI - Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance in untreated multiple myeloma patients. PG - 800-7 LID - 10.1200/JCO.2009.22.7561 [doi] AB - PURPOSE To evaluate the effect of bortezomib as induction therapy before autologous transplantation, followed by lenalidomide as consolidation-maintenance in myeloma patients. PATIENTS AND METHODS Newly diagnosed patients age 65 to 75 years were eligible. Induction (bortezomib, doxorubicin, and dexamethasone [PAD]) included four 21-day cycles of bortezomib (1.3 mg/m(2) on days 1, 4, 8, and 11), pegylated liposomal doxorubicin (30 mg/m(2) on day 4), and dexamethasone (40 mg/d; cycle 1: days 1 to 4, 8 to 11, and 15 to 18; cycles 2 to 4: days 1 to 4). Autologous transplantation was tandem melphalan 100 mg/m(2) (MEL100) and stem-cell support. Consolidation included four 28-day cycles of lenalidomide (25 mg/d on days 1 to 21 every 28 days) plus prednisone (50 mg every other day), followed by maintenance with lenalidomide (LP-L; 10 mg/d on days 1 to 21) until relapse. Primary end points were safety (incidence of grade 3 to 4 adverse events [AEs]) and efficacy (response rate). Results A total of 102 patients were enrolled. In a per-protocol analysis, after PAD, 58% of patients had very good partial response (VGPR) or better, including 13% with complete response (CR); after MEL100, 82% of patients had at least VGPR and 38% had CR; and after LP-L, 86% of patients had at least VGPR and 66% had CR. After median follow-up time of 21 months, the 2-year progression-free survival rate was 69%, and the 2-year overall survival rate was 86%. During induction, treatment-related mortality was 3%; grade 3 to 4 AEs included thrombocytopenia (17%), neutropenia (10%), peripheral neuropathy (16%), and pneumonia (10%). During consolidation-maintenance, grade 3 to 4 AEs were neutropenia (16%), thrombocytopenia (6%), pneumonia (5%), and cutaneous rash (4%). CONCLUSION Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance, is an effective regimen. FAU - Palumbo, Antonio AU - Palumbo A AD - Divisione di Ematologia dell'Universita di Torino, Azienda Ospedaliero-Universitaria San Giovanni Battista, Via Genova 3, 10126 Torino, Italy. appalumbo@yahoo.com FAU - Gay, Francesca AU - Gay F FAU - Falco, Patrizia AU - Falco P FAU - Crippa, Claudia AU - Crippa C FAU - Montefusco, Vittorio AU - Montefusco V FAU - Patriarca, Francesca AU - Patriarca F FAU - Rossini, Fausto AU - Rossini F FAU - Caltagirone, Simona AU - Caltagirone S FAU - Benevolo, Giulia AU - Benevolo G FAU - Pescosta, Norbert AU - Pescosta N FAU - Guglielmelli, Tommasina AU - Guglielmelli T FAU - Bringhen, Sara AU - Bringhen S FAU - Offidani, Massimo AU - Offidani M FAU - Giuliani, Nicola AU - Giuliani N FAU - Petrucci, Maria Teresa AU - Petrucci MT FAU - Musto, Pellegrino AU - Musto P FAU - Liberati, Anna Marina AU - Liberati AM FAU - Rossi, Giuseppe AU - Rossi G FAU - Corradini, Paolo AU - Corradini P FAU - Boccadoro, Mario AU - Boccadoro M LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20100104 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Boronic Acids) RN - 0 (Protease Inhibitors) RN - 0 (Pyrazines) RN - 0 (liposomal doxorubicin) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 4Z8R6ORS6L (Thalidomide) RN - 69G8BD63PP (Bortezomib) RN - 7S5I7G3JQL (Dexamethasone) RN - 80168379AG (Doxorubicin) RN - F0P408N6V4 (Lenalidomide) RN - Q41OR9510P (Melphalan) RN - VB0R961HZT (Prednisone) SB - IM EIN - J Clin Oncol. 2010 May 1;28(13):2314 MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Boronic Acids/administration & dosage MH - Bortezomib MH - Chemotherapy, Adjuvant MH - Dexamethasone/administration & dosage MH - Disease-Free Survival MH - Doxorubicin/administration & dosage/analogs & derivatives MH - Female MH - Humans MH - Italy/epidemiology MH - Kaplan-Meier Estimate MH - Lenalidomide MH - Male MH - Melphalan/administration & dosage MH - Middle Aged MH - Multiple Myeloma/*drug therapy/mortality/*surgery MH - Neoadjuvant Therapy MH - Polyethylene Glycols/administration & dosage MH - Prednisone/administration & dosage MH - Protease Inhibitors/administration & dosage MH - Pyrazines/administration & dosage MH - *Stem Cell Transplantation MH - Thalidomide/administration & dosage/analogs & derivatives MH - Time Factors MH - Transplantation, Autologous MH - Treatment Outcome EDAT- 2010/01/06 06:00 MHDA- 2010/03/05 06:00 CRDT- 2010/01/06 06:00 PHST- 2010/01/06 06:00 [entrez] PHST- 2010/01/06 06:00 [pubmed] PHST- 2010/03/05 06:00 [medline] AID - JCO.2009.22.7561 [pii] AID - 10.1200/JCO.2009.22.7561 [doi] PST - ppublish SO - J Clin Oncol. 2010 Feb 10;28(5):800-7. doi: 10.1200/JCO.2009.22.7561. Epub 2010 Jan 4.