Open Questions in Asia Pacific

Abstracts with a highly heterogeneous health status. Therefore, careful assessment of individuals’ condition is important in the execution of MM care. Methods: Here we assessed completed and ongoing clinical trials (CTs) in Europe and other CT endeavors that aim to improve diagnosis finding, treatment and prognosis for elderly MM pts. Results: Table 1 summarizes relevant CTs in elderly NDMM pts. Today, VMP, MPT and Rd are standards of care. Rd and MPR+R-maintenance are also effective induction options; and novel PI, IMiDs and Abs, reduced ASCT (DSMM XIII) and treatment optimization schedules are also eagerly assessed. Moreover, our aim is to earlier detect and treat ultra-high-risk and symptomatic MM, therefore tools and parameters allowing this and the definition of fitness in elderly pts are needed. For the latter, an ideally European- and world-wide harmonized Comorbidity and Functional Geriatric Assessment (CF-GA) should be valuable. In addition and in order to provide best possible pt care, MM-tumorboards are critical platforms which facilitate interdisciplinary state-of-the-art MM care, especially for challenging-to-treat pts. Conclusions: The majority of MM pts diagnosed today can expect to have disease control over long time periods, with access to all available therapies. In the attempt to define best therapeutic strategies, future CTs should not only 1. investigate prognostic parameters, 2. additional novel agents and 3. ideal combination schedules, but also 4. valuable disease response parameters within the BM and extramedullary sites, 5. the dynamics of clonal expansion and clonal diversity, and 6. best ways to approach these challenges. Another task remains to further improve and develop effective therapies for elderly and frail pts. In order to apply them, predictive CF-CA tools need to be assessed in prospective multicentre cohorts and included in future CTs.

PS-049 Ongoing Studies/Open Questions in Asia Pacific T. Ishida,1 A. Spencer,2 P.J. Hou,3 J.H. Lee,4 H. Kimura,5 K. Kubo,6 K. Sunami,7 S. Ozaki,8 N. Takezako,9 H. Handa,10 H. Kosugi,11 H. Murakami,12 K. Shimizu13 1

First Department of Internal Medicine, Sapporo Medical University

School of Medicine, Sapporo, Japan; 2Malignant Haematology &

University Graduate School of Health Science, Maebashi, Japan; 13

Hematology 1, Tokai Central Hospital, Kakamigahara, Japan

Background: There is the drug lag between US/EU and Asia Pacific, especially Asia. However, thalidomide was approved earlier than US/EU in Australia. In the ALLG-MM6 randomized study comparing consolidation thalidomide and prednisolone with prednisolone alone following ASCT, patients on consolidation thalidomide and prednisolone had superior PFS and OS. A. Spencer et al. are planning a Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-MLN9708 consolidation for transplant eligible MM patients undergoing a single ASCT. In Japan, the phase II study of bortezomib-melphalan-prednisolone (VMP) for NDMM using the same protocol of VISTA trial revealed that there were more treatment discontinuation in this study than in the VISTA study. From this data, we planned reduced intensity VMP for induction, consolidation of lenalidomide plus low dose dexamethasone (Rd) and maintenance of lenalidomide. Patients and methods: We included 82 pts with NDMM. Pts were received 5 cycles of VMP followed by 6 cycles of Rd. After Rd, pts received maintenance of lenalidomide. VMP included the IV or SQ administration of weekly bortezomib at 1.3 mg/m2 in combination with oral melphalan 6 mg/m2 and prednisone 60 mg/m2 once daily on days 1 e 4 of a 35-day cycle. Rd treatment consisted of lenalidomide 25 mg daily on days 1-21 plus dexamethasone 40 mg weekly of a 28-day cycle.. Lenalidomide maintenance therapy consisted of lenalidomide 10 mg daily on days 1-21 of a 28-day cycle. Results: In total, 82 pts were enrolled in the trial. Median age were 73.5 years (range 61 - 84), 45.1% were male. Fifty four patients had IgG-type myeloma (65.8%), 19 had IgA-type (23.2%), and9 had Bence Jones-type (11%). Among the study patients, 37.8% were 75 years of age or older, 21% had a b2-microgloblin level of more than 5.5 mg per liter. Of the cases analyzed by FISH (N¼80), 16.3% had t(4;14), 10% had del 17p and 41.3% had +1q21. The best response during VMP therapy (the maximum treatment number was 5 cycles) could be evaluated. The rates of partial response or better were 68% including sCR(5%), CR(6%),VGPR(20%) and PR(37%). The most commonly observed grade 3 or higher adverse events during VMP therapy were anemia (30%), neutropenia (16%), thrombocytopenia (5%) and GI toxicity (6%). Summary: The induction therapy of reduced intensity VMP was safe and effective. However, we need evaluate consolidation of Rd and maintenance of lenalidomide in the future.

Stem Cell Transplantation Department of Haematology Alfred HealthMonash University; 3Myeloma & Lymphoma Center, Department of Hematology, Chang Zheng Hospital, Shanghai, China; 4Gachon University Gil Medical Center, Incheon, South Korea; 5Kita-Fukushima Medical Center, Date, Fukushima, Japan; 6Aomori Prefectural Central Hospital, Aomori, Japan; 7Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan; 8

Department of Hematology Tokushima Prefectural Central Hospital,

Tokushima, Japan; 9Department of Hematology Disaster Medical Center of Japan, Tokyo, Jaopan;

10

Department of Medicine and

Clinical Science, Gunma University Graduate School of Medicine, Maebashi, Japan;

11

Department of Hematology, Ogaki Municipal

Hospital, Ogaki, Japan;

12

Department of Laboratory Science, Gunma

Celgene Corporation Sponsored Symposium: The Role of Immunomodulators in the Future Landscape of Multiple Myeloma

PS-050 Multiple Myeloma - Coping with a Disrupted Immune Environment K.C. Anderson Dana-Farber Cancer Institute and Beth Israel Hospital, Boston, USA

15th International Myeloma Workshop, September 23-26, 2015

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