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Dr. Palumbo - Bortezomib, Pegylated-Lyposomal-Doxorubicin and Dexamethasone Followed by Melphalan 100 mg/m in Elderly Newly Diagnosed Patients: An Interim Analysis
Antonio Palumbo, MD
Ospedale Molinette
Torino, Italy
Member,IMF Board of Scientific Advisors
12.23.07

"This study is suggesting something quite important: when you use new drugs as induction treatment before autologous transplant, you might achieve the same result with a lower dose of melphalan as with a full dose."
Dr. Antonio Palumbo


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[448] Bortezomib, Pegylated-Lyposomal-Doxorubicin and Dexamethasone Followed by Melphalan 100 mg/m in Elderly Newly Diagnosed Patients: An Interim Analysis. Session Type: Oral SessionAntonio Palumbo, Ilaria Avonto, Francesca Patriarca, Claudia Crippa, Maria T. Petrucci, Fausto Rossini, Paolo Corradini, Anna M. Liberati, Nicola Giuliani, Norbert Pescosta, Patrizia Falco, Alessandra Larocca, Paola Omedè, Massimo Offidani, Renato Fanin, Mario Boccadoro Divisione di Ematologia dellUniversit di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy; Italian Multiple Myeloma Network, GIMEMA, ItalyBortezomib has been evaluated as induction regimen to improve cyto-reduction before autologous stem cell transplant. Combinations including bortezomib, doxorubicin and dexamethasone have shown encouraging results. Melphalan at 100 mg/m has been suggested as reduced-intensity conditioning regimen for elderly patients. In this prospective multicenter phase II study, bortezomib, pegylated-liposomal-doxorubicin and dexamethasone (PAD) followed by tandem melphalan 100 mg/m has been investigated in newly diagnosed patients aged 65-75 years. The induction regimen included four 21-day PAD cycles (bortezomib 1.3 mg/m days 1, 4, 8, 11, pegylated-liposomal-doxorubicin 30 mg/m day 4 and dexamethasone 40 mg days 1-4, 8-11, and 15-18 for cycle 1 and days 1-4 for cycles 2-4). Cyclophosphamide (3 g/m) plus G-CSF were used to harvest stem cells. Patients were then conditioned with tandem melphalan 100 mg/m followed by stem cell infusion. A single interim analysis has been planned. Sixty-five patients have been enrolled in the study and 37 completed the induction cycles. Median age was 69 years; median 2-microglobulin 3 mg/L; median albumin 4.1 g/L; chromosome 13q deletion was detected by FISH in 35% of patients. After the 4 courses of PAD 97.1% of patients achieved at least a partial response (PR), 50% at least a very good partial response (VGPR), 11.8% an immunofixation negative complete remission (CR). After tandem melphalan 100 mg/m, all patients achieved at least a PR, 80% at least a VGPR and 30% an immunofixation negative CR. After 4 cycles of PAD, grade 3-4 hematologic events were thrombocytopenia (13.5%) and neutropenia (8.1%); more frequent grade 3-4 non-hematologic toxicities were peripheral neuropathy (21.6%) and infections (10.8%). One early toxic death was reported (central nervous system bleeding) and two patients had to discontinue therapy due to pneumonia and HBV reactivation. Eighty-two percent of patients achieved successful stem cell harvest (>4 CD34+ cells/Kg). PAD is an effective induction approach, it may improve autologous transplant results in selected elderly patients. Updated results of the interim analysis will be presented at the meeting.Abstract #448 appears in Blood, Volume 110, issue 11, November 16, 2007Keywords: Multiple Myeloma|Bortezomib|TransplantDisclosure: Membership Information: Prof. Boccadoro and Dr. Palumbo have scientic advisory board and speakers bureau from Johnson Johnson.Monday, December 10, 2007 2:15 PMSession Info: Simultaneous Session: Autologous Transplantation for Myeloma: Induction, Mobilization, and Biologic Correlates (1:30 p.m.-3:00 p.m.)


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