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

Clinical factors

  • 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.

Please see CARTITUDE-1 patient eligibility and exclusion criteria.

Treatment with CARVYKTI1

CARVYKTI™ certified healthcare facility or manufacturing site

Collaboration between primary oncology center and certified healthcare facility

Leukapheresis
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.
Bridging Therapy
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
Manufacturing

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.

Lymphodepletion
Patients are lymphodepleted with cyclophosphamide + fludarabine daily for 3 days (completed 2 to 4 days prior to infusion of CARVYKTI™).
Infusion of Car-t Cells

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.

Initial Monitoring

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