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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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

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.Check my eligibility
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.See study design
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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My kidney function is within the required range.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Secondary outcome measures
12-month overall survival
Complete response rate
Duration of response
+3 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Pain in extremity
14%
Lymphopenia
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Bone pain
9%
Leukopenia
9%
Urinary tract infection
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Abdominal pain upper
8%
Weight decreased
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Aspartate aminotransferase increased
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
5%
Bone Pain
5%
Throat irritation
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Squamous cell carcinoma of skin
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Acute myocardial infarction
1%
Pulmonary sepsis
1%
Pleural effusion
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
1%
Pathological fracture
1%
Pneumonia cytomegaloviral
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Gastroenteritis
1%
Humerus fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,237 Total Patients Enrolled
37 Trials studying Multiple Myeloma
3,444 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,380 Total Patients Enrolled
573 Trials studying Multiple Myeloma
188,018 Patients Enrolled for Multiple Myeloma
Scott R GoldsmithPrincipal InvestigatorCity of Hope Medical Center

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~6 spots leftby Mar 2025