Actively Recruiting
Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders
Led by University of Maryland, Baltimore · Updated on 2025-10-29
30
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of multiple myeloma (newly diagnosed or relapsed) or AL amyloidosis with planned daratumumab-based therapy
- No daratumumab treatment within 6 months prior to Cycle 1 Day 1 or no prior daratumumab exposure
- Signed written informed consent
- 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- History of autologous stem cell transplant or CAR-T therapy allowed if therapy was more than 100 days before enrollment and no active infections
- Adequate organ system function
- Female participants must not be pregnant or breastfeeding and meet contraceptive requirements
- Male participants must agree to contraceptive use during and for 6 months after treatment
- All prior treatment toxicities must be Grade 1 or less except alopecia and Grade 2 peripheral neuropathy
- Ability to comply with weekly visits for 9 weeks
You will not qualify if you...
- Systemic anti-myeloma therapy within 14 days or 5 half-lives before first dose or plasmapheresis within 7 days
- High dose steroids (>60 mg prednisone daily for 4 days or more) within 14 days if given for any disease
- Evidence of active bleeding
- Major surgery within the last 28 days
- Active renal condition that could affect safety except isolated proteinuria from multiple myeloma
- Serious or unstable medical or psychiatric disorders interfering with safety or compliance
- Unstable liver disease including ascites, encephalopathy, coagulopathy, hypoalbuminemia, varices, jaundice, or cirrhosis
- Other malignancies except those disease-free for more than 2 years or certain treated skin, prostate, cervical, or breast cancers
- COPD with FEV1 less than 50% of predicted normal
- Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
- History of significant cardiovascular disease including untreated arrhythmias, recent myocardial infarction or procedures, severe heart failure, or uncontrolled hypertension
- Known hypersensitivity to drugs related to daratumumab
- Active infection requiring treatment
- Positive hepatitis B surface antigen or core antibody, or positive hepatitis C antibody or RNA within 3 months prior to first dose
- Pregnant or lactating females
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
S
Sunita Philip
CONTACT
S
Stephanie Colbourn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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