drugset / Trial / NCT05363111
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.
Timeline
- Start
- 2022-11-22
- Primary completion
- 2027-03-23
- Completion
- 2027-03-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Actinium Ac 225-DOTA-Daratumumab | Monoclonal antibody | — | Intravenous |
| Subject | Indium In 111-DOTA-Daratumumab | Monoclonal antibody | — | Intravenous |
| Background | Daratumumab | Monoclonal antibody | — | Intravenous |