Actively Recruiting
Phase 1 Trial of 111Indium/225Actinium-DOTA-Daratumumab for Relapsed or Refractory Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2025-10-29
15
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating a combination treatment involving actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab), daratumumab, and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) for patients with multiple myeloma that has returned or does not respond to previous treatments. This phase I trial aims to test the safety, side effects, and best dose of these combined therapies, which use a monoclonal antibody linked to radioactive tracers to target and attack cancer cells. Patients receive daratumumab through an intravenous infusion lasting 45 minutes. Two hours later, they receive both 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab intravenously over 20 to 30 minutes. The study uses a dose-escalation approach to find the maximum tolerated dose and recommended dose for future studies. After treatment, patients are followed closely with weekly visits for 8 weeks, biweekly visits for 4 weeks, monthly visits for 16 weeks, and then periodic check-ups up to 12 months. During the study, participants will undergo multiple assessments including blood and bone marrow tests, imaging scans to track how the treatment spreads in the body, and evaluations of how well the cancer responds. Researchers will monitor side effects, overall response, survival rates, and how long the treatment controls the disease. The total involvement can last up to a year, with detailed follow-up to ensure safety and measure treatment effects.
CONDITIONS
Brief 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 and assent when appropriate
- Age 18 years or older
- Karnofsky performance status above 60%
- Diagnosed with multiple myeloma with measurable disease as defined by specific protein or light chain levels
- Received at least two prior lines of therapy
- Previously treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, and refractory to daratumumab
- CD38 expression confirmed on myeloma cells from bone marrow samples
- Refractory or intolerant to most recent therapy
- Fully recovered from acute toxic effects (except hair loss) of prior anti-cancer therapy to grade 1 or less
- Completed prior antitumor therapies within specified time frames before enrollment
- Absolute neutrophil count of at least 1,000/mm³ and platelets of at least 75,000/mm³ (or 50,000/mm³ with high marrow involvement) within 14 days prior to treatment
- Liver enzymes and kidney function within defined normal limits within 14 days prior to treatment
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during and for 6 months after the study
- Men must use barrier contraception and not donate sperm during the study and for 6 months after
You will not qualify if you...
- Received daratumumab or other anti-CD38 antibody within 3 months prior to enrollment
- Prior radiopharmaceutical therapy
- Detectable antibodies against daratumumab
- Previous radiation to more than 25% of bone marrow
- Female patients who are lactating or pregnant
- Major surgery within 14 days prior to study start
- Concurrent chemotherapy, radiation, or biologic cancer treatment; bone marrow stimulatory factors
- Vaccination with live vaccines within 4 weeks of study drug administration
- Diagnosis of primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS
- Severe persistent asthma or severe COPD with poor lung function
- Allergies or intolerance to monoclonal antibodies or related proteins
- Uncontrolled HIV, active hepatitis A, B, or C
- Significant abnormal ECG, advanced heart failure, recent heart attack, or unstable angina
- Other active cancers except certain skin and bladder cancers or carcinoma in situ
- Any condition that contraindicates participation or inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment administration
Participants receive daratumumab intravenously over 45 minutes. Two hours later, they receive 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab intravenously over 20-30 minutes.
1 treatment visit (in-person)
Duration - Up to 12 months
After treatment, participants 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 to monitor safety and treatment response.
Weekly visits for 8 weeks, biweekly visits for 4 weeks, monthly visits for 16 weeks, then periodic visits up to 12 months
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here