In relapsed or refractory multiple myelomaa
Determine if CARVYKTI™ is Right For Your Patient1
Key eligibility criteria from CARTITUDE-1a
- Patients with relapsed or refractory multiple myeloma who have previously been treated with four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Clinically fit patients (eg, good performance status and adequate organ function)b
- No prior treatment with an anti-BCMA targeting agent or CAR-T directed at any target
- Biomarker testing not required
- Prior ASCT not required
- No age restrictions for adults
- In the pivotal CARTITUDE-1 study, patients were not excluded based on tumor burden
ASCT=autologous stem cell transplant; BCMA=B cell maturation antigen; CAR-T=chimeric antigen receptor T cell; CD38=cluster of differentiation 38; CNS=central nervous system.
aSee key eligibility criteria from CARTITUDE-1.
bIn the pivotal CARTITUDE-1 study, patients were excluded from the trial due to any of the following: known active or prior history of significant CNS disease, including CNS multiple myeloma; plasma cell leukemia; allogeneic stem cell transplant ≤6 months before apheresis or ongoing treatment with immunosuppressants; creatinine clearance <40 mL/min; absolute lymphocyte concentration <300/μL; absolute neutrophil count <750 cells/mm3; platelet count <50,000/mm3; hepatic transaminases >3× the upper limit of normal; cardiac ejection fraction <45%; active serious infection; prior treatment with CAR-T directed at any target; or prior therapy targeting BCMA.
Treatment with CARVYKTI™1
CARVYKTI™ certified healthcare facility or manufacturing site
Collaboration between primary oncology center and certified healthcare facility
Patient immune cells are extracted over the course of 3 to 6 hours. The immune cells are then cryopreserved and sent to the manufacturing site. Leukapheresis is likely to be performed at the CARVYKTI™ certified healthcare facility.
Patients may receive additional therapy for disease control before their treatment with CARVYKTI™ at the discretion of the certified healthcare facility physician, who may consult with the primary oncologist
T cells are isolated after the cryopreserved leukapheresis material is thawed, and genetically modified to express the CARVYKTI™ CAR. After quality control release, CARVYTKI™ CAR-T cells are cryopreserved and returned to the certified healthcare facility for infusion.
Target 25-day turnaround CAR-T cell manufacturing timea
aDefined as time that elapses from receipt of apheresis at manufacturing site to quality assurance release of finished product.
Patients are lymphodepleted with cyclophosphamide + fludarabine daily for 3 days (completed 2 to 4 days prior to infusion of CARVYKTI™).
CARVYKTI™ is administered in a single 30- to 60-minute infusion at a CARVYKTI™ certified healthcare facility.
Patient should remain within proximity of the certified healthcare facility for at least 4 weeks following infusion.
CARVYKTI™ dose is 0.5-1.0 x 106 CAR+ viable T cells per kg body weight, with a maximum dose of 1 x 108 CAR+ viable T cells per one-time infusion.
Patients are monitored periodically for the first 4 weeks after CARVYKTI™ infusion, including daily at the certified healthcare facility for the first 10 days following CARVYKTI™ infusion.
Patients are monitored long term by their primary oncology care team in collaboration with the certified healthcare facility team.
CAR=chimeric antigen receptor; CAR-T=chimeric antigen receptor T cell.
Find a CARVYKTI™ Certified Treatment Center near you