(daratumumab)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
DARZALEX® (daratumumab)
Medical Information
Time Between Treatment Phases in the CASSIOPEIA Study
Last Updated: 09/17/2024
SUMMARY
Janssen does not recommend the use of DARZALEX in a manner that is inconsistent with the approved labeling. - CASSIOPEIA is a phase 3 study evaluating the safety and efficacy of DARZALEX in combination with bortezomib, thalidomide and dexamethasone (D-VTd) in transplant eligible patients with previously untreated multiple myeloma (MM).1
, 2 - Median time from last dose of induction until start of autologous stem cell transplantation (ASCT) was 1.61 months vs 1.53 months in the D-VTd vs VTd arm. See table: Gaps Between Treatment Phases.3
- Median time from last dose of induction until start of autologous stem cell transplantation (ASCT) was 1.61 months vs 1.53 months in the D-VTd vs VTd arm. See table: Gaps Between Treatment Phases.3
DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
CLINICAL DATA
Study Design/Methods
- The study design is presented in Figure: CASSIOPEIA Study Design.
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; max, maximum; 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.
a
b
c
- The Consolidation Phase of treatment began a minimum of 30 days post-ASCT, when the patient had recovered sufficiently, and engraftment was complete.3
Results
- Gaps between treatment phases for D-VTd vs VTd arm is presented in Table: Gaps Between Treatment Phases.3
| | Induction/ASCT/Consolidation | |
|---|---|---|
| D-VTd (n=536) | VTd (n=538) | |
| Time from last dose of induction until start of ASCT | ||
| n | 489 | 484 |
| Mean (SD) | 1.69 (0.584) | 1.64 (0.605) |
| Median (range), months | 1.61 (0.5-4.2) | 1.53 (0.1-5.2) |
| Time from last dose of induction until first dose of consolidation | ||
| n | 466 | 448 |
| Mean (SD) | 3.49 (0.661) | 3.42 (0.673) |
| Median (range), months | 3.48 (2.0-6.5) | 3.29 (1.9-6.3) |
| Time from last dose of DARZALEX induction until first dose of DARZALEX consolidation | ||
| n | 466 | - |
| Mean (SD) | 3.88 (0.653) | - |
| Median (range), months | 3.75 (2.4-6.9) | - |
| Abbreviations: ASCT, autologous stem cell transplantation; D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; SD, standard deviation; VTd, bortezomib + thalidomide + dexamethasone. | ||
A literature search of MEDLINE®
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 | |
| 3 |