SUMMARY

• Please refer to the local labeling for relevant information pertaining to warnings and precautions and post-infusion monitoring for CARVYKTI.¹
• Patients should be carefully monitored for 2 hours after CARVYKTI infusion for signs and symptoms of severe reaction.¹
• Monitor patients at least daily for 10 days following CARVYKTI infusion at a risk evaluation and mitigation strategy (REMS)-certified healthcare facility for signs and symptoms of cytokine release syndrome (CRS) and neurologic toxicities. Monitor periodically for 4 weeks for signs and symptoms of delayed neurologic toxicity.¹
• Instruct patients to remain within proximity of a REMS-certified healthcare facility for at least 4 weeks following infusion.¹
• CARTITUDE-1 (MMY2001) was a phase 1b/2 study that evaluated CARVYKTI in patients with relapsed/refractory multiple myeloma (RRMM) who had previously received a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-cluster of differentiation 38 (CD38) antibody.^2-4
  • Per protocol, patients were closely monitored for safety and disease assessments during the post-infusion period (day 1-100 after administration of CARVYKTI). During the post-treatment period (from day 101 to study completion), safety and disease assessments were conducted every 28 days.²
• CARTITUDE-4 (MMY3002) is a phase 3 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 of therapy (LOT).^5,6
  • Per protocol, patients were closely monitored for safety and disease assessments during the post-infusion period (day 1-112 after administration of CARVYKTI). During the post-treatment period (once the post-infusion follow-up is complete on day 112 to the end of the study [defined until approximately 250 deaths have occurred]), safety and disease assessments were conducted every 28 days.⁷

PRODUCT LABELING

• CARVYKTI (ciltacabtagene autoleucel) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;http://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; 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.^2-4

Study Design/Methods

• The study design is presented in Figure: CARTITUDE-1 Study Design.

• Per study protocol:
  • Patients were monitored during the post-infusion period (day 1-100 after administration of CARVYKTI) for safety and disease assessments including but not limited to monitoring for CRS, tumor lysis syndrome, cytopenias, infections, hypogammaglobulinemia and neurologic toxicities.² 
  • Patients were asked to check their temperature at least twice daily for 28 days and instructed to report any fever (≥100.4°F or ≥38°C) to the study doctor immediately to initiate monitoring for development of CRS.² 
  • Secondary primary malignancies (SPMs) were to be followed from the time of signing of informed consent form to study completion.²
  • The first 6 patients enrolled in the study were hospitalized for at least 2 weeks after receiving an infusion of CARVYKTI and were asked to remain within 1-hour travel time of the hospital and in the company of a competent adult at all times for 1 additional week after discharge. Patients who were not hospitalized were asked to remain within 1-hour travel time of the study site and in the company of a competent adult at all times for 2 weeks after receiving CARVYKTI.²
  • Patients were also monitored during the post-treatment period (day 101 until study completion) for safety and disease assessments every 28 days. Disease evaluation was to be performed until confirmed disease progression, death, start of new anticancer treatment, withdrawal of consent for study participation, or end of study (whichever occurs first).²

CLINICAL DATA - cartitude-4 - PHASE 3 STUDY

CARTITUDE-4 (MMY3002; NCT04181827) is a 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.^5,6

Study Design/Methods

• The study design is shown in Figure: CARTITUDE-4 Study Design.

• Per study protocol:
  • Patients were closely monitored during the post-infusion period (day 1-112 after administration of CARVYKTI) for safety and disease assessments including but not limited to CRS, neurotoxicity or other clinically significant events.⁷ 
  • SPMs were to be monitored continuously from randomization.⁷
  • Patients were asked to check their temperature at least twice daily (entering 2 temperatures including their maximum daily temperature on the provided diary) during the first 28 days after infusion and were instructed to report any fever (≥38°C or ≥100.4°F) to the investigator immediately to initiate monitoring for development of CRS.⁷
  • At the Investigator’s discretion and patient’s willingness, the patient was to be admitted for inpatient monitoring from the day of infusion (day 1) through day 14 of CARVYKTI infusion (with potential discharge on day 10 if there are no CRS, neurotoxicity or other clinically significant events), or was to receive CARVYKTI infusion as an outpatient in close proximity (within 30 min) to the hospital, be monitored for outpatient follow-up and then be admitted for the required inpatient monitoring from day 5 to day 14 after CARVYKTI infusion (with potential discharge on day 10 if there are no CRS, neurotoxicity or other clinically significant events).⁷
  • Patients were asked to remain within 1 hour of the hospital and in the company of a competent adult at all times for 1 additional week after hospital discharge or until study day 21, whichever occurred sooner.⁷
  • Patients were also monitored during the post-treatment period (once the post-infusion follow-up is complete on day 112 to the end of the study [defined until approximately 250 deaths have occurred]) for safety and disease assessments every 28 days.⁷
  • Patients were monitored for efficacy until confirmed progressive disease (PD), death, or withdrawal of consent. After confirmed PD, patients were followed for survival, subsequent anti-myeloma therapies, response to subsequent anti-myeloma therapies including the date of subsequent progression, and SPMs every 16 weeks until the end of study. The occurrence of SPMs must have been reported during the post-infusion and post-treatment follow-up and continue until the end of the study.⁷

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 02 April 2025.