Study on Daratumumab and Teclistamab Combination vs. Usual Treatment for High-Risk Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06948084
This clinical trial is comparing a new combination of medications, daratumumab and teclistamab, with the usual treatments for patients with high-risk multiple myeloma that hasn't responded to previous treatments or has returned after improvement.
Patient Parameters
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Program Overview
This study aims to find out if a new combination of drugs, daratumumab and teclistamab, is more effective than the usual treatments for patients with high-risk multiple myeloma that has either not responded to previous treatments or has come back. Daratumumab is a type of medication that helps the immune system target cancer cells, while teclistamab is designed to bind to specific proteins on cancer cells and immune cells to help stop the cancer from growing. The usual treatments involve daratumumab combined with either pomalidomide and dexamethasone or carfilzomib and dexamethasone, which work in different ways to fight cancer.
Description
The main goal of this study is to see if the combination of daratumumab and teclistamab can achieve better results in reducing cancer cells to undetectable levels compared to the usual treatments. Researchers will also look at the safety of the treatments, how long patients live without the cancer getting worse, and overall survival rates.
Participants will be randomly assigned to one of two groups. One group will receive the usual treatment, which includes daratumumab with either pomalidomide and dexamethasone or carfilzomib and dexamethasone. The other group will receive the new combination of daratumumab and teclistamab.
Throughout the study, participants will undergo regular tests, including blood and urine samples, bone marrow biopsies, and imaging scans, to monitor their response to the treatment. After completing the study treatment, participants will have follow-up visits every few months for up to 10 years to track their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a performance status score of 0-2, or 3 if due to pain.
- Must have a specific genetic marker identified through a test.
- Must have received only one prior line of therapy for multiple myeloma.
- Must have relapsed or refractory multiple myeloma, meaning the cancer has returned or not responded to previous treatment.
- Must not have received daratumumab or similar drugs recently, or must be sensitive to them.
- Must have high-risk multiple myeloma as defined by specific genetic tests or disease characteristics.
- Must have measurable disease based on specific medical tests.
- Must not have allergies to the study drugs or their components.
- Must not be on high-dose steroids at the time of joining the study.
- Must be able to understand and sign a consent form.
- Must have adequate blood counts and organ function based on specific tests.
- Must not be pregnant or breastfeeding and must agree to use contraception during the study.
- Must not have active central nervous system involvement of multiple myeloma.
- Must not have active autoimmune disease.
- Must have controlled HIV, hepatitis B, or hepatitis C infections if present.
- Must not have other medical conditions that could interfere with the study.
- Must have adequate heart and lung function based on specific tests.
- Must not have moderate or severe asthma recently.
- Investigator must choose the intended treatment regimen if assigned to the usual treatment group.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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