For adult patients with RRMM who received a PI and an immunomodulatory agent, and are lenalidomide-refractory
Determine if CARVYKTI® is Right For Your Patient1
Key Eligibility Criteria
- Received at least one prior line of
therapy, including a PI and an
immunomodulatory agent - Refractory to lenalidomide
- ECOG PS 0-1
Additional Considerations
- Prior CAR-T or BCMA-targeting therapy
- Known active or prior history of central nervous system involvement
- Exhibit clinical signs of meningeal involvement of MM
- History of Parkinson’s disease or other neurodegenerative disorder
BCMA=B-cell maturation antigen; CAR-T=chimeric antigen receptor-T cell; ECOG PS=Eastern Cooperative Oncology Group performance score; MM=multiple myeloma; PI=proteasome inhibitor.
CARVYKTI® TREATMENT PROCESS
Important Safety Information: Inform patients of the risk of early mortality. In a clinical study, treatment in the CARVYKTI® arm was associated with a higher rate of death (14%) compared to the control arm (12%) in the first 10 months from randomization. The higher rate of death was observed before receiving CARVYKTI® and after treatment with CARVYKTI® The reasons for death were progression of multiple myeloma and adverse events.
CARVYKTI® Certified Treatment
Center or manufacturing site
Collaboration between primary oncology center
and a CARVYKTI® Certified Treatment Center
Patient’s white blood cells are extracted over the course of approximately 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 Treatment Center.
Patients may receive additional therapy for disease control before their treatment with CARVYKTI® at the discretion of the CARVYKTI® Certified Treatment Center physician, who may consult with the primary oncologist.
T cells are isolated and genetically modified to express the CARVYKTI® CAR. After quality control release, the CARVYKTI® CAR-T cells are cryopreserved and returned to the CARVYKTI® Certified Treatment Center for infusion.
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 infusion that takes approximately 30 to 60 minutes at a CARVYKTI® Certified Treatment Center. Patients should remain within proximity of the CARVYKTI® Certified Treatment Center 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.
Delay the infusion of CARVYKTI® if your patient encounters:
- Clinically significant active infection or inflammatory disorders
- Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning, except for Grade 3 nausea, vomiting, diarrhea, or constipation. CARVYKTI® infusion should be delayed until resolution of these events to Grade ≤1
Patients are monitored periodically for the first 4 weeks after CARVYKTI® infusion, including daily at the CARVYKTI® Certified Treatment Center for the for the first 10 days following CARVYKTI® infusion.
Patients are monitored long term by their primary oncology care team in collaboration with the CARVYKTI® Certified Treatment Center team.
1LEUKAPHERESIS1,2
Patient’s white blood cells are extracted over the course of approximately 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 Treatment Center.
2Bridging therapy1
Patients may receive additional therapy for disease control before their treatment with CARVYKTI® at the discretion of the CARVYKTI® Certified Treatment Center physician, who may consult with the primary oncologist.
3Manufacturing1
T cells are isolated and genetically modified to express the CARVYKTI® CAR. After quality control release, the CARVYKTI® CAR-T cells are cryopreserved and returned to the CARVYKTI® Certified Treatment Center for infusion.
4LYMPHODEPLETION1
Patients are lymphodepleted with cyclophosphamide + fludarabine daily for 3 days (completed 2 to 4 days prior to infusion of CARVYKTI®).
5INFUSION1
CARVYKTI® is administered in a single infusion that takes approximately 30 to 60 minutes at a CARVYKTI® Certified Treatment Center. Patients should remain within proximity of the CARVYKTI® Certified Treatment Center for at least 4 weeks following infusion.
CARVYKTI® dose is 0.5-1.0 × 106 CAR+ viable T cells per kg body weight, with a maximum dose of 1 × 108 CAR+ viable T cells per one-time infusion.
Delay the infusion of CARVYKTI® if your patient encounters:
- Clinically significant active infection or inflammatory disorders
- Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning, except for Grade 3 nausea, vomiting, diarrhea, or constipation. CARVYKTI® infusion should be delayed until resolution of these events to Grade ≤1
6MONITORING1,3
Patients are monitored periodically for the first 4 weeks after CARVYKTI® infusion, including daily at the CARVYKTI® Certified Treatment Center for the for the first 10 days following CARVYKTI® infusion.
Patients are monitored long term by their primary oncology care team in collaboration with the CARVYKTI® Certified Treatment Center team.
CAR=chimeric antigen receptor; CAR-T=chimeric antigen receptor-T cell; RRMM=relapsed or refractory multiple myeloma.
Find A CARVYKTI® Certified Treatment Center Near You