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STEM CELL YIELD AND TRANSPLANTATION IN TRANSPLANT-ELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING DARATUMUMAB + BORTEZOMIB/THALIDOMIDE/DEXAMETHASONE (D-VTD): PHASE 3 CASSIOPEIA STUDY

PF598

Hulin, C.1; Moreau, P.2; Attal, M.3; Belhadj, K.4; Benboubker, L.5; Caillot, D.6; Facon, T.7; Garderet, L.8; Kuhnowski, F.9; Stoppa, A.-M.10; Kolb, B.11; Tiab, M.12; Sonneveld, P.13; Jie, K.-S.14; Westerman, M.15; Pei, L.16; Kampfenkel, T.17; de Boer, C.17; Vermeulen, J.17; van de Donk, N. W.18

doi: 10.1097/01.HS9.0000560680.23378.f5
Poster Session I: Myeloma and other monoclonal gammopathies - Clinical
Free

1Department of Hematology, Hospital Haut Leveque, University Hospital Bordeaux, Pessac

2Hematology, University Hospital Hôtel-Dieu, Nantes

3Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse

4Hematology, Hopital Henri Mondor, Creteil

5CHU de Tours, Hôpital de Bretonneau, Tours, Cedex 9

6CHU Dijon, Hôpital Du Bocage, Dijon

7Service des Maladies du Sang, Hôpital Claude Huriez, Lille

8Sorbonne Université, Centre de Recherche Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Département d'Hématologie et de Thérapie Cellulaire, Hôpital Pitié Salpetrière, département d'hématologie

9Institut Curie Paris, Paris

10Institut Paoli Calmettes, Marseille Cedex 9

11Hôpital Robert Debré, CHU de Reims, Reims Cedex

12CHD Vendée, La Roche sur Yon Cedex 9, France

13Erasmus MC Cancer Institute, Rotterdam

14Zuyderland MC, Sittard

15Northwest Clinics, Alkmaar, Netherlands

16Janssen Research & Development, Raritan, NJ, United States

17Janssen Research & Development, LLC, Leiden

18Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Amsterdam, Netherlands

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Background:

High-dose therapy (HDT) followed by autologous stem-cell transplantation (ASCT) is the standard of care in transplant-eligible newly diagnosed multiple myeloma (NDMM). In the phase 3 CASSIOPEIA study, daratumumab + standard-of-care regimen VTd (D-VTd) significantly improved stringent complete response (sCR), complete response or better (≥CR), and minimal residual disease (MRD)-negative rates and reduced the risk of progression or death versus VTd in NDMM patients who were eligible for transplant.

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Aims:

Here, we assessed stem cell yield and transplantation results among patients receiving D-VTd versus VTd induction prior to HDT and ASCT in Part 1 of the CASSIOPEIA trial.

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Methods:

In Part 1, transplant-eligible NDMM patients ages 18-65 years were randomized 1:1 to 4 pre-transplant induction and 2 post-transplant consolidation cycles of D-VTd or VTd alone. After induction, patients underwent stem cell mobilization with cyclophosphamide 3 g/m2 (recommended dose) and granulocyte colony-stimulating factor (G-CSF). Peripheral blood stem cells were harvested based on response to mobilization. Plerixafor was administered if stem cell collection failed at first attempt and in accordance with institutional practice. Melphalan 200 mg/m2 IV was given as HDT prior to ASCT.

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Results:

A total of 1,085 patients were randomized to D-VTd (n = 543) or VTd (n = 542). Among patients who completed mobilization (D-VTd, 506; VTd, 492), more patients in the D-VTd arm received plerixafor during mobilization than in the VTd arm (21.7% vs 7.9%). Patients underwent a median (range) of 2 (1-6) versus 1 (1-4) days of apheresis for D-VTd versus VTd. The median number of CD34+ cells collected was lower in patients receiving D-VTd versus VTd (6.3 × 106/kg vs 8.9 × 106/kg). Nevertheless, a similar percentage of intention-to-treat patients receiving D-VTd versus VTd underwent ASCT (90.1% vs 89.3%). The median number of CD34+ cells transplanted for D-VTd versus VTd was 3.3 × 106/kg versus 4.3 × 106/kg. Hematopoietic reconstitution rates were high and similar in transplanted patients receiving D-VTd versus VTd (99.8% vs 99.6%). For D-VTd versus VTd, a median (range) of 13.0 (6-54) versus 13.0 (4-43) days was required to achieve sustained absolute neutrophil counts >500 cells/mm3, and a median (range) of 14.0 (2-56) versus 12.0 (1-47) days was required to achieve sustained platelets >20,000 cells/mm3 without transfusion.

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Summary/Conclusion:

Stem cell mobilization and collection was feasible with D-VTd induction. Adding daratumumab to VTd allowed successful transplantation in patients with NDMM who were transplant eligible.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.