Imaging Studies and the Development of Multiple Myeloma
This study is not yet open for participant recruitment.
Verified January 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01571726
First received: April 4, 2012
Last updated: May 1, 2013
Last verified: January 2013
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Purpose
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....
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance |
Drug: Fluciclatide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Novel Imaging Modalities to Characterize Angiogenesis in the Bone Marrow Microenvironment in Multiple Myeloma (MM) and Its Precursor Disease |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Distribution of agent [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Fluciclatide
7mCi
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION CRITERIA:
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)
EXCLUSION CRITERIA:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571726
Contacts
| Contact: Mary Ann Yancey, R.N. | (301) 435-9227 | yanceym@mail.nih.gov |
| Contact: Carl O Landgren, M.D. | (301) 496-0670 | ol20z@nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Not yet recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Carl O Landgren, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT01571726 History of Changes |
| Other Study ID Numbers: | 120106, 12-C-0106 |
| Study First Received: | April 4, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
(18)-Fluciclatide PET/CT Serum M-Protein Percentage of Plasma Cells in the Bone Marrow Ratio of Normal/Abnormal Percentage of Plasma Cells in the Bone Marrow Multiple Myeloma |
Additional relevant MeSH terms:
|
Monoclonal Gammopathy of Undetermined Significance Paraproteinemias Multiple Myeloma Neoplasms, Plasma Cell Hypergammaglobulinemia Blood Protein Disorders Hematologic Diseases Immunoproliferative Disorders |
Immune System Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
ClinicalTrials.gov processed this record on May 16, 2013