Study on Ciltacabtagene Autoleucel and Talquetamab for Treating High-Risk Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT06550895
This clinical trial is exploring the safety of two treatments, Ciltacabtagene Autoleucel and Talquetamab, for patients with high-risk multiple myeloma, a type of blood cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to determine how safe the treatments Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab are for patients with high-risk multiple myeloma (MM), a serious form of blood cancer. The study will involve different groups of patients, including those who have received previous treatments and those who are newly diagnosed but cannot undergo high-dose chemotherapy with stem cell transplant.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma (MM) that can be measured at the start of the study.
- For certain groups (Cohorts 1 and 3), have received at least three previous treatments for MM and completed at least one full cycle of treatment.
- For another group (Cohort 2), be newly diagnosed with MM and unable to have high-dose chemotherapy with a stem cell transplant.
- For Cohorts 1 and 3, show evidence that the disease has progressed or did not respond to the last treatment.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women who can become pregnant must have a negative pregnancy test before starting the study.
Exclusion Criteria
- For Cohorts 1 and 3, have not received CAR-T cell therapy or any treatment targeting BCMA or GPRC5D before.
- For Cohort 2, have not received any treatment for MM or smoldering myeloma, except for a short course of steroids.
- For Cohorts 1 and 3, have not had an allogenic stem cell transplant within 6 months before starting the study or an autologous stem cell transplant within 12 weeks before starting the study.
- For Cohort 2, have not taken strong medications that affect liver enzymes within a certain period before starting specific induction therapy.
- Have not received a live vaccine within 4 weeks before joining the study.
- Have not fully recovered from side effects of previous cancer treatments, except for hair loss or mild nerve damage.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
