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Daratumumab infusion reaction study for patients with multiple myeloma

The purpose of this research study is to learn more about the risk of severe and fatal infusion-related reactions (IRR) in patients with multiple myeloma who are treated with their first 3 administrations of daratumumab. Examples of severe IRR include lung tightness, low oxygen levels, difficulty breathing, high blood pressure, racing heart, headache, and too much fluid in the lungs. No fatal IRRs have been observed in clinical trials of daratumumab. We are also doing this study to help us to identify potential risk factors for IRR.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

In this study, we will review your medical history, your medications, and any infusion-related reactions.

Total length of participation:
4 to 10 weeks

Looking for Specific Volunteers

Able to participate:

  • You must be starting daratumumab treatment for the first time in accordance with the approved label.

Not eligible if:

  • You have prior use of daratumumab or CD-38 antibody.
  • You have received an investigational drug or used an invasive investigational medical device within 2 weeks of the treatment before the start of the study.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Observational

Study Topics

Cancer (Multiple Myeloma)

IRB Number

23-2518

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