Imaging Studies and the Development of Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01571726|
Recruitment Status : Withdrawn
First Posted : April 5, 2012
Last Update Posted : December 16, 2019
- Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells, which help produce antibodies and fight infection. MM is nearly always preceded by a pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or SMM will develop MM. Also, the disease changes in those early states are not well understood. Researchers want to look at imaging studies of people with MGUS, SMM, and MM. They will study whether the growth of blood vessels can be used to predict disease progression.
- To use imaging studies to evaluate disease progression in multiple myeloma.
- Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM.
- Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and provide bone marrow samples.
- Participants will have positron emission tomography (PET) scans with the new contrast agent F-Fluciclatide. The contrast agent is intended to show patterns of increased vessel growth in the bone marrow.
- Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be done according to standard procedures.
- Researchers will compare these scans with blood tests and other clinical information to study disease progression of MGUS, SMM, and MM.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance||Drug: Fluciclatide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Imaging Modalities to Characterize Angiogenesis in the Bone Marrow Microenvironment in Multiple Myeloma (MM) and Its Precursor Disease|
|Study Start Date :||March 27, 2012|
|Actual Primary Completion Date :||April 23, 2014|
|Actual Study Completion Date :||April 23, 2014|
- Drug: Fluciclatide
- To explore the distribution of 18F-Fluciclatide PET/CT in bone marrow microenvironment in patients with multiple myeloma and its precursor disease (MGUS and SMM) [ Time Frame: 1 year ]
- Distribution of agent [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571726
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|