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 |
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Iowa Hospital and Clinics | 52242 | Iowa City | Iowa |
| Norton Cancer Institute | 40207 | Louisville | Kentucky |
| Barbara Ann Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Medical College Of Wisconsin | 53226 | Milwaukee | Wisconsin |
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