Study on Subcutaneous Daratumumab Injections in the Thigh vs. Abdomen for Plasma Cell Disorders

Sponsor: University of Maryland, Baltimore

Sponsor score: 0

ClinicalTrials ID:NCT07075510

Provider View

This clinical trial is exploring whether giving the medication daratumumab as an injection under the skin in the thigh is as safe and effective as giving it in the abdomen for patients with plasma cell disorders. Daratumumab is a treatment that helps the immune system target and destroy abnormal plasma cells.

Patient Parameters

Program Overview

The study aims to compare the safety and effectiveness of daratumumab injections given under the skin in the thigh versus the abdomen in patients with plasma cell disorders like multiple myeloma and AL amyloidosis. Daratumumab is a medication that targets a protein on abnormal plasma cells, helping to kill them or make them more visible to the immune system. The study will determine if thigh injections are a viable alternative for patients who find abdominal injections painful or difficult.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma or AL amyloidosis and planning to start treatment with daratumumab.
  • 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • If previously treated with daratumumab, it must have been more than 6 months ago.
  • Adequate organ function.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Men must agree to use contraception and not donate sperm during and for 6 months after treatment.
  • Able to attend weekly visits for 9 weeks.
  • All previous treatment side effects must be mild (Grade 1 or less), except for hair loss and mild nerve damage.

Exclusion Criteria

  • Recent treatment with anti-myeloma therapy or high-dose steroids.
  • Active bleeding or recent major surgery.
  • Serious or unstable medical conditions that could affect safety or study participation.
  • Active liver or kidney conditions that could affect safety.
  • Other cancers, unless disease-free for over 2 years, except for certain skin or prostate cancers.
  • Severe lung conditions like COPD or uncontrolled asthma.
  • Significant heart disease or uncontrolled high blood pressure.
  • Allergic reactions to daratumumab or similar drugs.
  • Active infections requiring treatment.
  • Positive tests for hepatitis B or C, unless resolved.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
University of Maryland Greenebaum Comprehensive Cancer Center21201BaltimoreMaryland

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