Radioimmunotherapy
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
What will happen during the trial?
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of 111In/225Ac-DOTA-daratumumab, at each dose level in order to establish the maximum tolerated dose (MTD), which will inform the recommended phase 2 dose (RP2D).
SECONDARY OBJECTIVES:
I. To describe the anti-myeloma activity of 225Ac-DOTA-daratumumab as assessed by overall response rate (ORR).
II. To evaluate the organ biodistribution, pharmacokinetics and organ dose estimates of 111In/225Ac-DOTA-daratumumab.
EXPLORATORY OBJECTIVE:
I. To assess the activity of 225Ac-DOTA-daratumumab against non-cancer immune cells using the peripheral blood and bone marrow (BM) samples.
OUTLINE: This is a dose-escalation trial of 225Ac-DOTA-daratumumab.
Patients receive daratumumab intravenously (IV) over 45 minutes. Two hours later, patients receive 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab IV over 20-30 minutes.
After completion of study treatment, patients are followed up weekly for 8 weeks, every 2 weeks for 4 weeks, every 4 weeks for 16 weeks, and then periodically up to 12 months.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 15 patients (estimated)
- Sponsors
- City of Hope Comprehensive Cancer Center
- Collaborators
- National Cancer Institute (NCI)
- Tags
- Monoclonal Antibody, CD38
- Trial Type
- Treatment
- Last Update
- SparkCures ID
- 1282
- NCT Identifier
- NCT05363111
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