Imaging Studies and the Development of Multiple Myeloma
Novel Imaging Modalities to Characterize Angiogenesis in the Bone Marrow Microenvironment in Multiple Myeloma (MM) and Its Precursor Disease
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
Background: \- 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. Objectives: \- To use imaging studies to evaluate disease progression in multiple myeloma. Eligibility: \- Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM. Design:
- 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 \[18\]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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Shorter than P25 for phase_2 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2012
CompletedFirst Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2014
CompletedDecember 16, 2019
April 16, 2014
2.1 years
April 4, 2012
December 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
1 year
Secondary Outcomes (1)
Distribution of agent
2 years
Interventions
7mCi
Eligibility Criteria
You may qualify if:
- Diagnosis of MGUS, SMM and MM will be made in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group. The diagnosis will be confirmed by the following diagnostic tests:
- serum/urine protein electrophoresis
- serum/urine immunofixation,
- light-chain assays,
- a skeletal survey, or
- immunohistochemistry analyses of the bone marrow biopsy, or
- a combination of these at the NIH
- Note: Written results from institutions outside of NIH for the above tests will be accepted if available.
- Age greater than or equal to 18 years.
- ECOG performance status of 0-2.
- The patient must be competent to sign an informed consent form.
- Platelet count = or \> 100,000. Subjects must weight \<320lbs
- Creatinine \<2.5 times ULN or eGFR\>30 ml/min/1.73m(2)
You may not qualify if:
- A medical history of other malignancy (apart from basal cell carcinoma of the skin or in situ cervical carcinoma; also, for MM patients this does not include MM) except if the patient has been free of symptoms and without active therapy during at least the previous 3 years.
- Patients with documented metastatic lesions from another type of malignancy will be excluded.
- Female subject is pregnant or breast-feeding.
- The subject has known allergy to gadolinium
- The subject has contraindications to MRI
- Subjects must weigh \<136 kg (weight limit for scanner table).
- Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Kyle RA, Rajkumar SV. Multiple myeloma. Blood. 2008 Mar 15;111(6):2962-72. doi: 10.1182/blood-2007-10-078022.
PMID: 18332230BACKGROUNDInternational Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol. 2003 Jun;121(5):749-57.
PMID: 12780789BACKGROUNDKumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008 Mar 1;111(5):2516-20. doi: 10.1182/blood-2007-10-116129. Epub 2007 Nov 1.
PMID: 17975015BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl O Landgren, M.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 5, 2012
Study Start
March 27, 2012
Primary Completion
April 23, 2014
Study Completion
April 23, 2014
Last Updated
December 16, 2019
Record last verified: 2014-04-16