Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05363111
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2022-05-03
Brief Title:
Radioimmunotherapy 111Indium225Actinium-DOTA-daratumumab for the Treatment of RelapsedRefractory Multiple Myeloma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase 1 Trial of 111Indium225Actinium-DOTA-Daratumumab in Patients With RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVE
I To assess the safety and tolerability of 111In225Ac-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 111In225Ac-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
I To assess the safety and tolerability of 111In225Ac-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 111In225Ac-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-03039 | REGISTRY | None | None |
| 21599 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA033572 |