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Dosage and Administration - Restarting after Prolonged Interruptions

Last Updated: 10/08/2024

Abbreviations: ASCT, autologous stem cell transplantation; C, cycle; CD, cluster of differentiation; CR, complete response; CTCAE, Common Terminology Criteria for Adverse Events; D, daratumumab; d, dexamethasone; D-VTd, daratumumab + bortezomib + thalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; HDT, high-dose chemotherapy; IV, intravenous; MM, multiple myeloma; MRD, minimal residual disease; NGS, Next-generation sequencing; ORR, overall response rate; OS, overall survival; PCD, plasma cell dyscrasia; PCL, plasma cell leukemia; PD, progressive disease; PFS, progression-free survival; PFS2, PFS after the next line of therapy; PO, per oral; PR, partial response; QW, once a week; Q2W, every 2 weeks; Q8W, every 8 weeks; SC, subcutaneous; sCR, stringent complete response; T, thalidomide; TTP, time to progression; V, bortezomib; VTd, bortezomib + thalidomide + dexamethasone.
aMoreau (2019)1. bMoreau (2021)2. cBegan after hematopoietic reconstitution but not earlier than 30 days after transplant. dDaratumumab or other anti-CD38 therapies. eIn patients with CR at a threshold of 10-5 by NGS.

Abbreviations: ASCT, autologous stem cell transplantation; D-VTd, daratumumab + bortezomib + thalidomide + dexamethasone; IRRs, infusion related reactions; IV, intravenous.
fData on file (2019).3

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Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 07 October 2024.

References

1 Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29-38.  
2 Moreau P, Hulin C, Perrot A, et al. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(10):1378-1390.  
3 Data on File. Clinical Study Report 54767414MMY3006. Janssen Research & Development, LLC. EDMS-ERI-172588360; 2019.