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Daratumumab Administration in Plasma Cell Disorders

This study is looking at the safety and tolerability of Daratumumab when given as an injection under the skin (subcutaneously) in either the thigh or the abdomen. Daratumumab is a monoclonal antibody, a type of drug that can find and destroy abnormal plasma cells in conditions like multiple myeloma or AL amyloid. It works by targeting a protein called CD38 on these cells. The study aims to see if there are any differences in side effects based on where the injection is given. You may be able to join if you have a plasma cell disorder and are planning to receive Daratumumab, and have not received it before or not in the last 6 months. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This study is an interventional trial, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
The study will measure side effects from the first dose (week 1) up to 8 doses (week 9).
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured from the first dose (week 1) up to 8 doses (week 9).

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NCT07075510

Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~30 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:Daratumumab Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over Time of first dose (week 1), up to 8 doses (week 9)

Conditions

Plasma Cell Disorder

Explore related trials

Multiple MyelomaPrimary Amyloidosis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Ashraf Badros, MD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore Greenebaum Comprehensive Cancer Center

Who to contact

Sunita Philip
[email protected]
410-328-8199
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.
We will review the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a new undetected pregnancy.
≥45 years of age and has not had menses for \>1 year
Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. 8. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
Must agree to use contraception/barrier and use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential 9. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy. 10. Participants are able to comply with visit schedule and agree to weekly visits for 9 weeks

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Time of first dose (week 1), up to 8 doses (week 9)

    To characterize the safety and tolerability of subcutaneous daratumumab administered in the thigh vs the abdomen in patients with plasma cell disorders. Frequency and incidence rate of adverse events by type, severity, timing, and attribution to study drug, according to the NCI-CTCAE version 5.0.