Actively Recruiting
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2025-10-29
15
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Age 18 years or older
- Karnofsky performance status greater than 60%
- Diagnosed multiple myeloma with measurable disease by specific protein levels
- Received at least two prior lines of therapy
- Previously treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody; refractory to daratumumab
- CD38 expression confirmed on myeloma cells
- Refractory or intolerant to most recent therapy
- Recovered from prior anti-cancer therapy side effects to grade 1 or less, except hair loss
- Completed prior treatments within specified timeframes before enrollment
- Absolute neutrophil count of 1,000/mm³ or higher
- Platelet count of 75,000/mm³ or higher (or 50,000/mm³ if marrow involvement is 50% or more)
- Liver and kidney function within specified normal limits
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential must use effective birth control during and 6 months after study
- Men sexually active with women of childbearing potential must use barrier contraception and avoid sperm donation during and 6 months after study
- Childbearing potential defined as no surgical sterilization or absence of menses for over one year
You will not qualify if you...
- Daratumumab or other anti-CD38 antibody treatment within 3 months before enrollment
- Previous radiopharmaceutical therapy
- Detectable antibodies against daratumumab
- Previous radiation to more than 25% of bone marrow
- Pregnant or breastfeeding women
- Major surgery within 14 days before study treatment
- Receiving concurrent chemotherapy, radiation, or biologic cancer treatments
- Use of bone marrow stimulatory factors
- Vaccination with live attenuated vaccines within 4 weeks before treatment
- Diagnosis of primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS syndrome
- Severe persistent asthma or severe COPD
- Known allergies or intolerance to monoclonal antibodies or related substances
- Uncontrolled HIV or active hepatitis infections
- Significant heart conditions including recent heart attack or unstable angina
- Presence of active malignancy except certain treated skin or bladder cancers and in situ carcinomas
- Any condition that makes participation unsafe or compliance unlikely according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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