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

Recruiting Phase 1 Phase 2 Interventional Study
Plasma Cell Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of Maryland, Baltimore · Other
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About This Trial
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 sys…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed diagnosis of MM (newly diagnosed or relapsed) or AL amyloid with planned therapy with daratumumab-based regimen. and has not received daratumumab previously or has received daratumumab \> 6 months prior to planned Cycle 1 Day 1 alone or in combination…
Contacts

Sunita Philip

410-328-8199

sphilip1@umm.edu

CONTACT

Stephanie Colbourn

410-328-8199

stephanie.colbourn@umm.edu

CONTACT