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Radioimmunotherapy for Multiple Myeloma
Study Summary
This trial is testing a combination of two different radioimmunotherapies (RITs) targeting daratumumab, in order to treat patients with refractory or recurrent multiple myeloma. Daratumumab is a monoclonal antibody that interferes with the growth and spread of cancer cells. The two RITs, 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab, are forms of targeted radiation delivery that use the daratumumab antibody to target cancer cells specifically. The purpose of this trial is to test the safety and efficacy of this
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT02136134Trial Design
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- Your absolute neutrophil count is at least 1,000 per cubic millimeter.I have not had a heart attack in the last 12 months.You have a serious abnormality in your heart's electrical activity as shown by an ECG test.I am a man and will use protection if I have sex with a woman who can have children.I have severe asthma or COPD with daily symptoms or low lung function.I have uncontrolled HIV or active hepatitis.You are allergic to monoclonal antibodies or human proteins.I do not have unstable or poorly controlled chest pain.My multiple myeloma cells show CD38 expression.I am capable of becoming pregnant or fathering a child.Your alanine aminotransferase (ALT) level should be less than or equal to three times the upper limit of normal (ULN).My kidney function is within the required range.I have another active cancer besides the one being treated.I have recovered from side effects of cancer treatment, except for hair loss.I have severe heart failure.I have not received any live vaccines in the last 4 weeks.I have been diagnosed with a rare blood disorder.I am 18 years old or older.I can care for myself but may need occasional help.Your platelet count is at least 75,000 per cubic millimeter (or at least 50,000 per cubic millimeter if more than half of your bone marrow is affected).Your bilirubin levels should be within a certain range, unless you have Gilbert's disease.Your AST blood test results are not more than three times the upper limit of normal.I am a woman who can have children and my pregnancy test is negative.I have had radiation on more than a quarter of my bone marrow.I have undergone at least two different treatments.I am currently undergoing chemotherapy, radiation, or biologic treatment for cancer.I am not pregnant or breastfeeding.I have not had major surgery in the last 14 days.I haven't had Daratumumab or any anti CD38 treatment in the last 3 months.I have had radiopharmaceutical therapy before.You have antibodies in your body that fight against daratumumab.I have multiple myeloma with measurable signs according to IMWG criteria.I have been treated with drugs targeting proteins, immune system, and CD38.My condition did not improve after taking daratumumab.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
Has the Daratumumab treatment been validated by U.S. government regulatory procedures?
"Our team ranked the safety of Daratumumab as a 1 due to this being an early-stage clinical trial with restricted evidence concerning its efficacy and security."
Approximately how many individuals are being analyzed as part of this medical experiment?
"Affirmative. According to the information accessible on clinicaltrials.gov, this experiment is actively searching for volunteers and was initially posted on November 30th 2022 with its most recent update occurring October 7th 2022. The trial requires 15 individuals from a single site."
Is there still availability for participation in this clinical trial?
"As per the records posted on clinicaltrials.gov, this trial is currently in need of participants having been initially published on November 30th 2022 and last updated October 7th of the same year."
What overarching goals does this research endeavor hope to achieve?
"This clinical trial is designed to assess dose-limiting toxicities (DLTs) over a 6 week period. The secondary objectives include assessing the overall response rate, complete response rate and 12 month overall survival using International Myeloma Working Group criteria for partial response, very good partial response, complete response or stringent complete responses."
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