Study on Teclistamab and Talquetamab Combinations with Daratumumab and Lenalidomide for Newly Diagnosed Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05552222
This clinical trial is comparing two new treatment combinations for people with newly diagnosed multiple myeloma, a type of blood cancer. The study aims to find out if these new combinations are more effective than the current standard treatment.
Patient Parameters
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Program Overview
The study is testing two new treatment combinations for people with newly diagnosed multiple myeloma, a type of blood cancer. One combination includes the drugs teclistamab, daratumumab, and lenalidomide (Tec-DR), and the other includes talquetamab, daratumumab, and lenalidomide (Tal-DR). These will be compared to the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd) to see which is more effective.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma, a type of blood cancer.
- Newly diagnosed and not suitable for high-dose chemotherapy with stem cell transplant due to age, other health conditions, or choosing to delay this treatment.
- Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Agree not to be pregnant, breastfeeding, or planning to become pregnant during the study and for 6 months after the last treatment.
- Agree not to father a child during the study and for 100 days after the last treatment.
Exclusion Criteria
- Have not received any prior treatment for multiple myeloma, except for a short course of corticosteroids.
- Have not had plasmapheresis within 28 days before starting the study.
- Have not had a stroke, mini-stroke, or seizure in the last 6 months.
- Do not have known allergies or intolerances to the study drugs.
- Do not have contraindications to using daratumumab or lenalidomide.
- Do not have a high frailty score, unless it is due to age alone.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mission Cancer Blood | 50309 | Des Moines | Iowa |
| Cancer And Hematology Centers of Western Michigan PC | 49503 | Grand Rapids | Michigan |
| University of Nebraska Medical Center | 68198 0600 | Omaha | Nebraska |
| Durham VAMC | 27705 | Durham | North Carolina |
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