Study on Multi-Target Immunotherapy for High-Risk Multiple Myeloma
Sponsor: University of Arkansas
ClinicalTrials ID:NCT07029776
This clinical trial is exploring whether using two immunotherapy drugs, teclistamab and talquetamab, at different times can help improve survival in patients with high-risk Multiple Myeloma. The study involves a series of treatments, including chemotherapy, stem cell collection, and possibly a stem cell transplant, depending on the presence of myeloma cells in the bone marrow.
Patient Parameters
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Program Overview
The aim of this study is to find out if using the immunotherapy drugs teclistamab and talquetamab at different stages can help patients with high-risk Multiple Myeloma live longer. Participants will undergo several treatments, starting with chemotherapy and stem cell collection. If tests show that myeloma cells are still present, a stem cell transplant will be performed. If not, the transplant will be skipped. All participants will then receive further immunotherapy and maintenance treatments.
Description
This study is designed to see if a combination of immunotherapy drugs can improve outcomes for patients with high-risk Multiple Myeloma. The study will be conducted in phases, starting with chemotherapy to control the disease and collect stem cells. Participants will then receive immunotherapy with teclistamab and talquetamab. If tests show that myeloma cells are still present, a stem cell transplant will be performed. If not, the transplant will be skipped. All participants will continue with additional immunotherapy and maintenance treatments to help keep the cancer under control. The study will measure how many patients achieve a complete response and how long they remain free from disease progression over two years.
Eligibility Criteria
Inclusion Criteria
- Must have newly diagnosed active Multiple Myeloma that requires treatment.
- Can have a history of smoldering myeloma if treatment is now needed.
- Must not have received more than two months of treatment for Multiple Myeloma, except for bisphosphonates and localized radiation.
- Must have high-risk disease features, such as specific genetic abnormalities or other indicators.
- Must be between 18 and 75 years old.
- Must have adequate kidney, heart, and lung function.
- Must be able to understand and sign a consent form.
- Women must use effective birth control during the study and for six months after.
- Men must not donate sperm during the study and for three months after.
Exclusion Criteria
- Cannot have poorly controlled high blood pressure, diabetes, or other serious illnesses.
- Cannot have had another cancer, except for certain skin cancers or other cancers treated with curative intent.
- Cannot be pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
- Cannot have severe lung disease or uncontrolled asthma.
- Cannot have active autoimmune diseases or infections.
- Cannot have significant heart disease or recent heart attack.
- Cannot be positive for HIV, active hepatitis B, or hepatitis C.
- Cannot have had plasmapheresis within 28 days of starting the study treatment.
- Cannot have had recent radiation therapy, except for certain cases.
- Cannot have allergies to specific study drugs or their components.
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