SUMMARY

• EMagine/CARTITUDE-6 is an ongoing phase 3, randomized, open label, multicenter, global study comparing the efficacy and safety of DARZALEX FASPRO^® (daratumumab and hyaluronidase), bortezomib, lenalidomide, and dexamethasone (DVRd) followed by CARVYKTI vs DVRd followed by autologous stem cell transplant (ASCT) in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The study results have not been published.^1,2
• CARVYKTI is not approved by the regulatory agencies for use in NDMM. Janssen does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.

PRODUCT LABELING

• CARVYKTI (ciltacabtagene autoleucel) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;  https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf.
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.

CLINICAL DATA

EMagine/CARTITUDE-6 (MMY3005; EMN28; clinicaltrials.gov identifier: NCT05257083) is an ongoing phase 3, randomized, open-label, multicenter, global study comparing the efficacy and safety of DVRd followed by CARVYKTI vs DVRd followed by ASCT in patients with NDMM. In this study, the efficacy of induction treatment with DVRd followed by ASCT, DVRd consolidation, and maintenance treatment with lenalidomide will be compared with induction treatment with DVRd followed by single infusion of CARVYKTI followed by maintenance treatment with lenalidomide.^1,2

Study Design/Methods

• The study design is shown in Figure: EMagine/CARTITUDE-6 Study Design.
• Patients will be randomized 1:1 to receive the following treatments^1,2:
  • Arm A: Standard therapy (DVRd + ASCT + DVRd)
    • Patients will receive DVRd for 4 induction cycles followed by ASCT and 2 cycles of DVRd consolidation. Each 28-day cycle will include:
      • DARZALEX FASPRO: 1800 mg subcutaneously (SC) on days 1, 8, 15 and 22 (cycles 1 and 2) and on days 1 and 15 (cycles 3-6).
      • Bortezomib: 1.3 mg/m² SC on days 1, 4, 8, and 11 of each cycle (cycles 1-6).
      • Lenalidomide: 25 mg orally (PO) on days 1-21 of each cycle (cycles 1-6).
      • Dexamethasone: 40 mg PO once per week on days 1, 8, 15 and 22 of each cycle (cycles 1-6).
    • Patients will receive oral lenalidomide maintenance: 10-15 mg on days 128 continuously until confirmed disease progression or unacceptable toxicity or for a maximum duration of 2 years.
  • Arm B: Experimental therapy (DVRd followed by CARVYKTI)
    • Patients will undergo apheresis at randomization followed by 6 cycles of DVRd induction. Each 28-day cycle will include:
      • DARZALEX FASPRO: 1800 mg SC on days 1, 8, 15 and 22 (cycles 1 and 2) and on days 1 and 15 (cycles 3-6).
      • Bortezomib: 1.3 mg/m² SC on days 1, 4, 8, and 11 of each cycle (cycles 1-6).
      • Lenalidomide: 25 mg PO on days 1-21 of each cycle (cycles 1-6).
      • Dexamethasone: 40 mg PO once per week on days 1, 8, 15 and 22 of each cycle (cycles 1-6).
    • Following induction, patients will undergo lymphodepletion (cyclophosphamide 300 mg/m² and fludarabine 30 mg/m² daily for 3 days).
    • Patients will receive a single infusion of CARVYKTI at a target dose of 0.75×10⁶ CAR+ T cells/kg, 5-7 days after the start of lymphodepletion.
    • Patients will receive oral lenalidomide maintenance: 10-15 mg on days 128 continuously until confirmed disease progression or unacceptable toxicity or for a maximum duration of 2 years.

Results

• Study results have not been published.

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 19 August 2024.