Imaging Studies and the Development of Multiple Myeloma

• Status: Withdrawn
• Trial end date: 2014-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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.