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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 below
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I am a man and will use protection if I have sex with a woman who can have children.
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My multiple myeloma cells show CD38 expression.
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I am capable of becoming pregnant or fathering a child.
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I have recovered from side effects of cancer treatment, except for hair loss.
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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.
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I have undergone at least two different treatments.
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I have multiple myeloma with measurable signs according to IMWG criteria.
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I have been treated with drugs targeting proteins, immune system, and CD38.
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My condition did not improve after taking daratumumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe asthma or COPD with daily symptoms or low lung function.
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I have uncontrolled HIV or active hepatitis.
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I do not have unstable or poorly controlled chest pain.
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I have another active cancer besides the one being treated.
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I have severe heart failure.
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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.
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I am currently undergoing chemotherapy, radiation, or biologic treatment for cancer.
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I am not pregnant or breastfeeding.
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I have not had major surgery in the last 14 days.
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I have had radiopharmaceutical therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

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 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
44%
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.

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

Actinium Ac 225-DOTA-Daratumumab (Radioimmunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05363111 — Phase 1
Actinium Ac 225-DOTA-Daratumumab (Radioimmunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363111 — Phase 1
Multiple Myeloma Research Study Groups: Treatment (daratumumab, 225Ac/111In-DOTA-daratumumab)
Multiple Myeloma Clinical Trial 2023: Actinium Ac 225-DOTA-Daratumumab Highlights & Side Effects. Trial Name: NCT05363111 — Phase 1
~2 spots leftby Mar 2025