Study Comparing Two Treatment Approaches for Newly Diagnosed Multiple Myeloma: DVRd with Ciltacabtagene Autoleucel vs. DVRd with Stem Cell Transplant
Sponsor: Stichting European Myeloma Network
ClinicalTrials ID:NCT05257083
This clinical trial is comparing two treatment methods for patients with newly diagnosed multiple myeloma. One group will receive a combination of drugs followed by a new type of cell therapy, while the other group will receive the same drugs followed by a stem cell transplant.
Patient Parameters
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Program Overview
The study aims to find out which treatment is more effective for newly diagnosed multiple myeloma: a combination of drugs (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone) followed by a new cell therapy called Ciltacabtagene Autoleucel, or the same drug combination followed by a traditional stem cell transplant. The study will involve about 750 participants, who will be randomly assigned to one of the two treatment groups.
Description
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, leading to the production of abnormal proteins. This study is testing a new treatment approach using a cell therapy called Ciltacabtagene Autoleucel, which is a type of CAR-T therapy targeting a specific protein on cancer cells. The goal is to see if this new therapy can improve outcomes for patients compared to the standard treatment of a stem cell transplant. Participants will be randomly assigned to receive either the new cell therapy or the stem cell transplant after initial treatment with a combination of drugs. The study will measure how long patients remain free from disease progression and other health outcomes.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of newly diagnosed multiple myeloma (NDMM) and are eligible for high-dose therapy and stem cell transplant as part of their initial treatment plan.
- Have measurable disease based on specific laboratory tests, such as:
- Serum M-protein level of at least 1.0 g/dL or urine M-protein level of at least 200 mg/24 hours.
- For light chain multiple myeloma without measurable disease in serum or urine: serum free light chain (FLC) level of at least 10 mg/dL and an abnormal serum kappa lambda FLC ratio.
- Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have clinical laboratory values within specified ranges.
Exclusion Criteria
- Have received any prior CAR-T therapy targeting any protein.
- Have received any prior therapy targeting BCMA.
- Have received any prior treatment for multiple myeloma or smoldering myeloma, except for a short course of corticosteroids.
- Have taken a strong CYP3A4 inducer within five half-lives before randomization.
- Have received or plan to receive any live, attenuated vaccine (except COVID-19 vaccines) within four weeks before randomization.
- Have known active or prior central nervous system involvement or signs of meningeal involvement of multiple myeloma.
- Have had a stroke or seizure within six months of signing the informed consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas | 72205 | Little Rock | Arkansas |
| City of Hope | 91010 | Duarte | California |
| UC San Diego Health Moores Cancer Center | 92037 | San Diego | California |
| University of California San Francisco (UCSF) | 94143 | San Francisco | California |
| Stanford University | 94305 | Stanford | California |
| Moffitt Cancer Center | 12902 | Tampa | Florida |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Iowa | 52242 | Iowa City | Iowa |
| The University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
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