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Radioimmunotherapy
Radioimmunotherapy for Multiple Myeloma
Phase 1
Recruiting
Led By Scott R Goldsmith
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men who are sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
CD38 expression on multiple myeloma (MM) cells from bone marrow aspirate or biopsy as demonstrated by flow cytometry or immunohistochemistry
Must not have
Severe persistent asthma (forced expiratory volume in 1 second [FEV1] < 60% and/or daily symptoms) or severe chronic obstructive pulmonary disease (COPD)
Subject has uncontrolled human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial tests a new treatment for patients with difficult-to-treat or returning multiple myeloma. The treatment aims to target and kill cancer cells more effectively by delivering radiation directly to them.
Who is the study for?
This trial is for adults over 18 with multiple myeloma that's resistant to treatment or has returned. They must have tried at least two prior therapies, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 monoclonal antibody. Participants need good organ function and performance status, not be pregnant or breastfeeding, use effective birth control if applicable, and can't have other active cancers or severe lung/heart conditions.
What is being tested?
The trial tests the safety and optimal dose of a new therapy combining three agents: Actinium Ac 225-DOTA-daratumumab (radioimmunotherapy), Daratumumab (monoclonal antibody), and Indium In 111-DOTA-daratumumab (another radioimmunotherapy). This combination aims to target cancer cells more effectively in those with refractory or recurrent multiple myeloma.
What are the potential side effects?
Potential side effects include reactions related to the infusion of antibodies such as fever or chills; radiation-related issues like nausea; blood count changes leading to increased infection risk; liver function alterations; allergic responses; fatigue; heart complications due to radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man and will use protection if I have sex with a woman who can have children.
Select...
My multiple myeloma cells show CD38 expression.
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I am capable of becoming pregnant or fathering a child.
Select...
I have recovered from side effects of cancer treatment, except for hair loss.
Select...
I am 18 years old or older.
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I can care for myself but may need occasional help.
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I am a woman who can have children and my pregnancy test is negative.
Select...
I have undergone at least two different treatments.
Select...
I have multiple myeloma with measurable signs according to IMWG criteria.
Select...
I have been treated with drugs targeting proteins, immune system, and CD38.
Select...
My condition did not improve after taking daratumumab.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe asthma or COPD with daily symptoms or low lung function.
Select...
I have uncontrolled HIV or active hepatitis.
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I do not have unstable or poorly controlled chest pain.
Select...
I have another active cancer besides the one being treated.
Select...
I have severe heart failure.
Select...
I have not received any live vaccines in the last 4 weeks.
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I have been diagnosed with a rare blood disorder.
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I have had radiation on more than a quarter of my bone marrow.
Select...
I am currently undergoing chemotherapy, radiation, or biologic treatment for cancer.
Select...
I am not pregnant or breastfeeding.
Select...
I have not had major surgery in the last 14 days.
Select...
I have had radiopharmaceutical therapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose-limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Secondary study objectives
12-month overall survival
Complete response rate
Duration of response
+3 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Asthenia
15%
Insomnia
13%
Cough
11%
Nausea
11%
Pyrexia
11%
Dizziness
11%
Neuralgia
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Hyperglycaemia
7%
Pain in extremity
6%
Pain in Extremity
6%
Paraesthesia
6%
Headache
6%
Bronchitis
6%
Arthralgia
5%
Epistaxis
5%
Bone pain
5%
Bone Pain
5%
Decreased Appetite
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
5%
Hypocalcaemia
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Abdominal pain
4%
Alanine aminotransferase increased
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Abdominal pain upper
3%
Hypertension
3%
Abdominal Pain Upper
3%
Hypophosphataemia
3%
Conjunctivitis
3%
Rash
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Urinary tract infection
2%
Herpes Zoster
1%
Weight decreased
1%
Pulmonary Embolism
1%
Nasal congestion
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Sepsis
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Syncope
1%
Productive cough
1%
Lower respiratory tract infection
1%
Respiratory failure
1%
Chills
1%
Gastroenteritis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Awards & Highlights
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)Experimental Treatment3 Interventions
Patients receive daratumumab IV over 45 minutes. Two hours later, patients receive 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab IV over 20-30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments often involve monoclonal antibodies, proteasome inhibitors, and immunomodulatory drugs. Monoclonal antibodies, such as daratumumab, target specific proteins on myeloma cells to induce cell death through immune-mediated mechanisms.
Proteasome inhibitors, like bortezomib, disrupt protein degradation in cancer cells, leading to apoptosis. Immunomodulatory drugs, such as lenalidomide, enhance the immune system's ability to attack myeloma cells and inhibit their growth.
Radioimmunotherapy, like 225Ac-DOTA-daratumumab, combines targeted antibody therapy with radioactive isotopes to deliver lethal radiation directly to cancer cells, minimizing damage to surrounding tissues. These mechanisms are crucial for effectively reducing tumor burden and improving patient outcomes in Multiple Myeloma.
Relapsed/Refractory multiple myeloma: defining refractory disease and identifying strategies to overcome resistance.Complement and cellular cytotoxicity in antibody therapy of cancer.
Relapsed/Refractory multiple myeloma: defining refractory disease and identifying strategies to overcome resistance.Complement and cellular cytotoxicity in antibody therapy of cancer.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,590 Total Patients Enrolled
38 Trials studying Multiple Myeloma
3,500 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,078 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,402 Patients Enrolled for Multiple Myeloma
Scott R GoldsmithPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Multiple Myeloma
20 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Timeline:
This trial has the following timeline:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)
Awards:
This trial has 2 awards, including:- 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.