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NCT03910439 · ClinicalTrials.gov registry record · Phase 2
Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03910439: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03910439 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03910439, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively. Objective: To see if avelumab given with radiation treatment helps treat multiple myeloma. Also to see if giving the treatments together is safe. Eligibility: People ages 18 and older with multiple myeloma that has come back after treatment and has spread to other parts of the body Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible tumor biopsy Bone marrow testing: A needle will be stuck into the participants hipbone to take out a small amount of marrow. Positron emission tomography (PET)/Computed tomography (CT) scan and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body. Participants will get avelumab through an intravenous (IV). An IV is a small plastic tube put into an arm vein. They will get avelumab every 2 weeks for 2 doses. Then they will get radiation each day for 5 days. They will continue to get avelumab every 2 weeks as long as they do not have bad side effects and the treatment is helping their disease. Participants will have blood and urine tests, bone marrow biopsies, scans, and X-rays repeated during the study. Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for up to 5 years....
Interventions
- RADIATION External beam radiotherapy
- BIOLOGICAL Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2020-11-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910439
The ClinicalTrials.gov registry entry for NCT03910439 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which External beam radiotherapy is the first listed.
NCT03910439 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03910439 about?
NCT03910439 is a clinical study titled "Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma". Background: Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively. Obje...
What is the current status of trial NCT03910439?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-10-17. Estimated completion is 2020-11-04.
What interventions are being tested in trial NCT03910439?
The interventions under investigation include: External beam radiotherapy (RADIATION), Avelumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03910439?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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