Summary

• CARTITUDE-1 (MMY2001) was a phase 1b/2, open-label, single-arm, multicenter study evaluating CARVYKTI in patients with relapsed/refractory multiple myeloma (RRMM) who had previously received a proteasome inhibitor (PI), an immunomodulatory agent, and an antiCD38 antibody. The combined analysis from the phase 1b/2 portions of the CARTITUDE-1 study evaluated the safety and efficacy of CARVYKTI in 97 patients with RRMM.^1,2,5
• CARTITUDE-4 (MMY3002) is a phase 3, randomized, open-label study evaluating the efficacy and safety of CARVYKTI versus standard care (physician's choice of pomalidomide, bortezomib, and dexamethasone [PVd] or DARZALEX FASPRO^® [daratumumab and hyaluronidase], pomalidomide, and dexamethasone [DPd]) in adult patients with lenalidomide-refractory multiple myeloma (MM) after 1-3 prior line(s) of therapy (LOT).^3,4
• The washout periods for CARTITUDE-1 and CARTITUDE-4 are summarized below.

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 - CARTITUDE-1 - PHASE 1B/2 STUDY

CARTITUDE-1 (MMY2001; clinicaltrials.gov identifier: NCT03548207) was a
phase 1b/2, open-label, single-arm, multicenter study that evaluated the safety and efficacy of CARVYKTI in patients with RRMM who had previously received a PI, an immunomodulatory agent, and an antiCD38 antibody. The combined analysis from the phase 1b/2 portions of the CARTITUDE-1 study evaluated the safety and efficacy of CARVYKTI in 97 patients with RRMM.^1,2,5

• In CARTITUDE-1, a washout period from bridging therapy was required prior to administration of the lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine.⁶
• Patients were excluded from participation in the study if they received prior antitumor therapy as follows, prior to apheresis/leukapheresis⁶:
  • Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less.⁶
  • Monoclonal antibody treatment for multiple myeloma within 21 days.⁶
  • Cytotoxic therapy within 14 days.⁶
  • PI within 14 days.⁶
  • Immunomodulatory agent within 7 days.⁶
  • Radiotherapy within 14 days. However, patients were eligible irrespective of the end date of radiotherapy if the radiation portal covered ≤5% of the bone marrow reserve.⁶
  • Received a cumulative dose of corticosteroids equivalent to ≥70 mg prednisone within the 7 days prior to apheresis or the first dose of lymphodepleting regimen.⁶

Clinical data - CARTITUDE-4 - Phase 3 study

CARTITUDE-4 (MMY3002; clinicaltrials.gov identifier: NCT04181827) is an ongoing, phase 3, randomized, open-label study evaluating the efficacy and safety of CARVYKTI versus standard care (physician's choice of PVd or DPd) in adult patients with lenalidomide-refractory MM after 1-3 prior LOT.^3,4

• In CARTITUDE-4, patients in the CARVYKTI arm had to have received a washout period that occurred from the last dose of bridging therapy until prior to initiating the conditioning regimen (cyclophosphamide and fludarabine), the length of which depended on whether PVd or DPd was given as bridging therapy.⁷
  • Cycles beyond bridging cycle 1 may have been truncated to allow for adequate washout and minimize time off therapy.⁷
• Patients were excluded from participation in the study if they received prior antitumor therapy as follows, prior to randomization⁷:
  • Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less.
  • Investigational vaccine within 4 weeks.
  • Monoclonal antibody treatment within 21 days.
  • Cytotoxic therapy within 14 days.
  • PI within 14 days.
  • Immunomodulatory agent therapy within 7 days.
  • Radiotherapy within 14 days. However, if the radiation is given for palliative purposes and the radiation portal covered ≤5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy. Radiotherapy within 14 days on measurable extramedullary plasmacytoma(s) is not permitted even in the setting of palliation for symptomatic management.
  • Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone within the 7 days prior to randomization or conditioning regimen.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 28 January 2025.