Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography

A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients

[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.

Inclusion Criteria:

• Subject is over 19 years old and male or female of any race/ethnicity
• Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist
• Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected
• Subject has voluntarily agreed to participate in the study

Exclusion Criteria:

• Subject or subject's legally acceptable representative does not provide written informed consent.
• Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of [18F]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
• Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator.
• Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
• Subject has been previously included in this study.
• Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
• Subject is allergic to Florbetaben or any of ingredients of Florbetaben