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NCT07075510 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders
A Phase 1 study of Plasma Cell Disorder, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07075510 is a Phase 1 study of Plasma Cell Disorder that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 30 participants, below the 104-participant average among 4 other Plasma Cell Disorder trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07075510, a Phase 1 study of Plasma Cell Disorder, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab. Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein. Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker. However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug. This study will
Conditions Studied
Interventions
- DRUG Daratumumab Injection
Study Locations (1)
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-23 |
| Est. Completion | 2032-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07075510
The ClinicalTrials.gov registry entry for NCT07075510 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 4 other Plasma Cell Disorder trials with a reported enrollment target (71% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Plasma Cell Disorder appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab Injection is the first listed.
NCT07075510 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT07075510 about?
NCT07075510 is a clinical study titled "Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders". The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface ...
What is the current status of trial NCT07075510?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-10-23. Estimated completion is 2032-10-01.
What conditions does trial NCT07075510 study?
This clinical trial studies the following conditions: Plasma Cell Disorder.
What interventions are being tested in trial NCT07075510?
The interventions under investigation include: Daratumumab Injection (DRUG).
Who is sponsoring clinical trial NCT07075510?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07075510 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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