XII International Myeloma Workshop 2008, 93 patients (44%) were randomized: 54 in arm A and 39 in arm B. The median follow-up from diagnosis was 15 months. PFS in arm A and arm B were 42% and 25%, P = .07. A multivariate analysis that included B2M and del13 showed that Thal was associated with better PFS (HR, 2.43, P = .03). Overall survival was 65% in arm A and 74% in arm B, P = NS. Conclusion: This study shows that the addition of Thal to dexamethasone improves PFS after ASCT.
A502 The Impact of Age in the Long-Term Outcome of Patients with Newly Diagnosed Multiple Myeloma A Garcia, A Sureda, C Canas, JJ Lahuerta, J De la Rubia, R García-Sanz, R Martínez, J García-Laraña, F de Arriba, JM Ribera, M Hernández, L Escoda, D Carrera, MJ Terol, J Besalduch, F Casado, J Bladé, J San Miguel The Spanish Group of Multiple Myeloma (GEM)/PETHEMA
Objectives: We have analysed the impact of age at diagnosis on the outcome of patients with multiple myeloma under 70 years enrolled in a prospective clinical trial with double stemcell transplantation. Patients and Methods: First line treatment consisted on six alternating cycles of VBCMP/VBAD followed by a first autologous transplantation (ASCT) and a second stem cell transplantation (either an ASCT or a reduced intensity allogeneic stem cell transplantation) in those patients not achieving a complete remission. 1060 patients were enrolled in the study (group 1: < 60 years: 538 patients; group 2: >60y: 522 patients). At diagnosis, only ECOG (ECOG 2-4: group 1: 42% vs group 2: 48%, p=0.036) and serum albumine (albumine<3.5 g/dl: group 1: 39% vs group 2: 46%, p= 0.049) were significantly different in both groups. In patients with available cytogenetic results (group 1: n= 122; group 2: n= 240), the incidence of IgH translocations and Rb deletion was significantly increased in the younger group (group 1: 43% vs group 2: 30%, p = 0.033 and group 1: 48% vs group 2: 35%, p=0.038, respectively). Results: The compliance of protocol was worse in the older group both at the time of the first ASCT and second transplant. The response rate was not different in the different phases of protocol in both groups but treatmentrelated mortality was significantly superior in the older group of patients in relation to the younger one after the first ASCT (3% vs 6%, p=0.04). After a median follow-up of 39 (35-43) months, overall survival (OS) and event-free survival (EFS) at 3 years for all patients was 71% and 53%, respectively. Both OS and EFS were significantly better in the young group [OS: 73% vs 69% at 3y, p=0.003] and [EFS: 59% vs 47% at 3y, p<0.001]. Multivariate analysis showed that age was a independent prognostic factor for both OS and EFS, as well as a IgA, hiperkaliemia, ECOG 2-4 and 2 o more cytogenetic abnormalities. Conclusion: Advanced age at diagnosis was associated to a significantly poorer compliance of the different steps of the protocol. In addition, it appeared as an independent adverse prognostic factor for both OS and EFS.
A504 Consolidation Therapy with Thalidomide Improves Survival Post ASCT NJ Bahlis, P Neri, P Duggan, A Mansoor, B Rolan, D Stewart University of Calgary
Background: High-dose chemotherapy and autologous stem cell rescue (ASCT) have increased the survival of multiple myeloma patients. However, this therapeutic approach is not curative due to persistent minimal residual disease or contamination of the graft. Effective maintenance or consolidation strategies post transplant will likely prolong the duration of response and survival post ASCT. Methods: We have conducted a retrospective analysis of the role of maintenance or consolidation treatment with thalidomide post ASCT. Within 3 months after high-dose therapy, 129 patients younger than age 65 years received no maintenance (n=84; arm A) or thalidomide 100-200mg for 6-18 months (n=45; arm B). FISH data was available on 58 patients, with 24 patients defined as High-risk (HR) based on the presence of t(4;14) or deletion17p13. Results: Post-ASCT and prior to starting maintenance thalidomide, complete (CR) or very good partial response (VGPR) was achieved by 75% of patients in arm A and 73.3% in arm B. Overall the median time to progression (mTTP) post transplant was not different with a mTTP of 2.4 years (CI: 2.2-2.7 years) in arm A and 3.1 years (CI: 2.5-3.7 years) in arm B (P = 0.296). However among patients who failed to achieve CR or VGPR, 3 months post ASCT, thalidomide significantly improved the mTTP from 1.6 years (CI:0.3-2.8) in arm A to 3.6 years (CI:2.6-4.6) in Arm B (P = 0.003). Among patients with High-risk disease, as defined by FISH, thalidomide significantly improved the mTTP from 0.8 years (CI:0.4-1.6 years) to 2.8 years (CI:1.7-4.0 years) (P = 0.017). The 6-year post-ASCT probability of survival was 52.8% in arm A and 66% in arm B (P = 0.469). Conclusion: Thalidomide is an effective maintenance or consolidation therapy in patients with multiple myeloma who fail to achieve CR/VGPR post transplant and in patients with FISH-defined high-risk disease. These results support the investigation of other novel agents (Lenalidomide, Bortezomib) in consolidation post ASCT.”
A508 Treatment Response and Survival in Myeloma Renal Failure J Behrens,1 D Makanjuola2 1
St. Bartholomew’s Hospital, London, UK; 2St. Helier Hospital,
London, UK
Introduction and Aims: To compare response to treatment and outcomes of an unselected group of MM patients presenting to a regional renal unit between 2000-2007 with historical reports and to create a baseline with which new therapies can be compared. Material and Methods: Information was collected retrospectively on 62 patients with MM and renal failure severe enough to be
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