Phase 1 Trial of 111Indium/225Actinium-DOTA-Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
City of Hope Medical Center
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.
Description
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 per…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age \>= 18 years * Karnofsky performance status (KPS) \> 60% * Multiple myeloma according to International Myeloma Working Group (IMWG) criteria with measurable disease defined as one of the following: * Serum monoclonal protein \>= 1.0 g/dL (or 0.5 g/dL in patients with immunoglobulin A \[IgA\] multiple myeloma \[MM\]) * 24 hour urine monoclonal protein \>= 200 mg/24 hour * Serum free light chain (F…
Interventions
- BiologicalActinium Ac 225-DOTA-Daratumumab
Given IV
- BiologicalDaratumumab
Given IV
- BiologicalIndium In 111-DOTA-Daratumumab
Given IV
Location
- City of Hope Medical CenterDuarte, California