Teclistamab-Daratumumab for AL Amyloidosis
This study is looking at a combination of two drugs, teclistamab and daratumumab, to see if they are safe and effective for people with AL amyloidosis. AL amyloidosis is a condition where abnormal proteins called amyloid build up in organs. Teclistamab works by targeting specific cells (T-cells and plasma cells), and daratumumab targets a protein (CD38) on myeloma cells. The main goal is to see if this combination can lead to a complete blood response (Hematologic Complete Response) within 6 months. You might be able to join if you are 18 years or older. The study aims to reduce harmful proteins in your blood to prevent organ damage, improve organ function, and help you live longer.
- Study design
- This is an interventional study planning to enroll 25 participants. It is designed to assess the effectiveness and safety of the teclistamab-daratumumab combination.
- What's involved
- The study treatment is divided into cycles, with each cycle lasting 28 days. The expected duration of study treatment is 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Hematologic Complete Response, is measured at 6 months from treatment initiation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Teclistamab-Daratumumab in AL Amyloidosis
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Rajshekhar Chakraborty, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Hematologic Complete Response (Heme-CR) rate6 months from treatment initiation
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.