Study Comparing T-cell Engager Therapy and Stem Cell Transplant in Multiple Myeloma
Sponsor: SCRI Development Innovations, LLC
ClinicalTrials ID:NCT06974786
This clinical trial is exploring two different treatment approaches for patients with newly diagnosed multiple myeloma who have already received initial therapy. The study aims to compare the effectiveness of a T-cell engager therapy with a stem cell transplant followed by additional treatments.
Patient Parameters
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Program Overview
This study is designed to compare two treatment strategies for patients with newly diagnosed multiple myeloma who have already undergone initial therapy. The main goal is to see which approach is better at eliminating any remaining cancer cells in the bone marrow. One group will receive a combination of elranatamab and daratumumab, while the other group will undergo a stem cell transplant followed by treatment with lenalidomide and daratumumab. The study will also look at how well patients respond to these treatments over time.
Description
This clinical trial involves patients with newly diagnosed multiple myeloma who have already received initial treatment with specific drugs. Participants will be randomly assigned to one of two groups. One group will receive a combination of elranatamab and daratumumab as a follow-up treatment, while the other group will undergo a stem cell transplant followed by treatment with lenalidomide and daratumumab. The study will monitor how well these treatments work in eliminating cancer cells from the bone marrow. If any cancer cells remain after one year, patients may switch to the other treatment option. The study will also track patients who achieve complete remission to see if the cancer returns. Elranatamab is a drug that helps the immune system target and destroy myeloma cells, while daratumumab is a therapy that targets a specific protein on cancer cells.
Eligibility Criteria
Inclusion Criteria
- Age over 18 years, no upper age limit.
- Newly diagnosed multiple myeloma within the last 12 months, needing treatment.
- Eligible for stem cell transplant based on doctor's evaluation.
- Good overall health with a performance status of 0 or 1.
- Completed initial therapy with specific drugs for 16-24 weeks, achieving at least partial response.
- Measurable disease based on specific criteria at diagnosis.
- Ability to track cancer cells using a specific test.
- Meet certain blood and organ function criteria.
- Achieved at least partial response to initial therapy.
- Completed stem cell collection without chemotherapy mobilization.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception.
- Men must use condoms during the study and for 90 days after the last treatment.
- Willing to follow study requirements and sign informed consent.
- Agree to participate in specific safety programs for study drugs.
Exclusion Criteria
- Certain other types of blood disorders or cancers.
- Allergies or intolerances to study drugs.
- Previous treatment with specific therapies or investigational drugs.
- Active central nervous system involvement by myeloma.
- Other active cancers requiring treatment in the last 24 months, with some exceptions.
- Recent stroke or seizure.
- Severe lung or asthma conditions.
- Previous organ transplant.
- Pregnant or breastfeeding women, or those planning to become pregnant.
- Men planning to father a child during or shortly after the study.
- Certain heart conditions or recent heart events.
- Active infections or certain viral infections.
- Recent major surgery or planned surgery during the study.
- Intolerance to required supportive care medications.
- Significant nerve damage or history of certain neurological conditions.
- Other medical or psychiatric conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Oncology Hematology Care | 45242 | Cincinnati | Ohio |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Virginia Oncology Associates | 23502 | Norfolk | Virginia |
| University of Wisconsin Clinical Science Center | 53792 | Madison | Wisconsin |
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