OncoMatch/Clinical Trials/NCT07075510
Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders
Is NCT07075510 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Daratumumab for plasma cell disorder.
Treatment: Daratumumab — 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 take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson \& Johnson Innovative Medicine (J\&J IM).
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: daratumumab (daratumumab)
Exception: has not received daratumumab previously or has received daratumumab > 6 months prior to planned Cycle 1 Day 1
has not received daratumumab previously or has received daratumumab > 6 months prior to planned Cycle 1 Day 1
Cannot have received: systemic anti-myeloma therapy
Systemic anti-myeloma therapy within ≤14 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug
Cannot have received: plasmapheresis
plasmapheresis within 7 days prior to the first dose of study drug
Cannot have received: high dose steroids (prednisone)
Systemic treatment with high dose steroids (equivalent to >60 mg prednisone daily for ≥4 days) within the past 14 days
Lab requirements
Blood counts
Adequate organ system function
Kidney function
Adequate organ system function; active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety) excluded; isolated proteinuria from MM allowed
Liver function
Adequate organ system function; unstable liver disease excluded (ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis)
Cardiac function
History of cardiovascular disease excluded: clinically significant untreated arrhythmias, ECG abnormalities (Mobitz Type II or third degree AV block), MI, acute coronary syndromes, angioplasty, stenting, bypass grafting within 3 months, NYHA Class III/IV heart failure, uncontrolled hypertension
Adequate organ system function; unstable liver disease excluded; active renal condition excluded; cardiovascular disease excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify