RecruitingPhase 1NCT05363111

Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma

Phase 1 Trial of 111Indium/225Actinium-DOTA-Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma

Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of targeted radiation treatment using radioactive antibodies (daratumumab labeled with indium-111 or actinium-225) to destroy multiple myeloma cells in people whose cancer has returned or stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older with a Karnofsky performance status above 60% - You have multiple myeloma with measurable disease (by blood, urine, or free light chain tests) - Your myeloma has returned or stopped responding to previous treatments **You may NOT be eligible if...** - You have poor kidney, liver, or bone marrow function - You are unable to follow the study's procedures or consent requirements - You have active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALActinium Ac 225-DOTA-Daratumumab

Given IV

BIOLOGICALDaratumumab

Given IV

BIOLOGICALIndium In 111-DOTA-Daratumumab

Given IV

Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05363111

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