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NCT01109407 · ClinicalTrials.gov registry record
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)
A clinical trial, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- 225
- Enrollment target
NCT01109407: Clinical Trial study, sponsored by National Cancer Institute (NCI).
NCT01109407 is a clinical trial that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 225 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109407 was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- 225 participants
- Enrollment target
Study Summary
Background: \- Multiple myeloma is a type of cancer that affects white blood cells and has a poor long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into multiple myeloma. Researchers are interested in collecting samples from individuals who have been diagnosed with MGUS and SMM to study possible risk factors for developing multiple myeloma. Objectives: \- To study risk factors that may cause MGUS and SMM to progress to multiple myeloma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with either MGUS or SMM but do not have multiple myeloma. Design: * Participants will be examined by study researchers at the initial visit, at 6 months following enrollment, and every 12 months for a maximum of 5 years. * The following tests may be performed: (1) blood and urine tests, (2) bone marrow aspiration and biopsy, (3) imaging studies, and (4) a skeletal survey (a series of skeletal X-rays of the skull, spine, pelvis, ribs, shoulders, upper arm, and thigh bones). * Treatment will not be provided as part of this protocol. - Participants will remain on the study for 5 years, or until their MGUS or SMM progresses to multiple myeloma requiring treatment.
Primary Outcome
determination of subtypes of MM based on GEP, and determination of prognostic indicators
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2010-04-22 |
| Est. Completion | 2021-02-25 |
Why NCT01109407 stopped before completion
NCT01109407 is an observational study that tracks outcomes without assigning an intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01109407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109407 about?
NCT01109407 is a clinical study titled "Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)". Background: \- Multiple myeloma is a type of cancer that affects white blood cells and has a poor long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into multiple myeloma. Re...
What is the current status of trial NCT01109407?
This trial is currently terminated. The enrollment target is 225 participants. The study started on 2010-04-22. Estimated completion is 2021-02-25.
Who is sponsoring clinical trial NCT01109407?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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