Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT01955395
Eligibility Criteria:
Inclusion Criteria:
* Participants must have confirmed high-risk monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) as defined below in table #.
MGUS
* Serum monoclonal protein level \< 3 g/dL but \> 1.5g/dl,
* Bone marrow plasma cells \< 10%
* Non-IgG MGUS (ie IgA, IgM, IgD MGUS)
* Abnormal serum free light chain ratio (ie ratio of kappt to lambda free light chains \< 0.26 or \> 1.65)
* Absence of end-organ damage, such as lytic bone lesions, anemia, hypercalcemia, or renal failure, that can be attributed to a plasma cell proliferative disorder
SMM (also referred to as asymptomatic multiple myeloma)
* Serum monoclonal protein (IgG or IgA) level \> 3 g/dL,
* and /or bone marrow plasma cells \> 10%,
* absence of end-organ damage, such as lytic bone lesions, anemia, hypercalcemia, or renal failure, that can be attributed to a plasma cell proliferative disorder
* Participants must be at least 18 years old. Because no dosing or adverse event data are currently available on the use of RR in participants \<18 years of age, children are excluded from this study.
* The effects of RR on the developing human fetus are unknown. For this reason, should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
* Participants with concurrent active cancer or active cancer with in the last 5 years are ineligible.
* Participants with serious or unstable illness, as determined by study physicians and clinicians, may be deemed unfit to participate.
* Participants with current bipolar or psychotic disorders with active symptoms or treatment within the last 5 year will be excluded.
* Participants will be excluded if they are currently taking (within the last 6 months) psychoactive medications (e.g. mood stabilizers, antipsychotics), with the exception of hypnotics and antidepressants, which will be permitted.
* Participants may not be receiving any other study agents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01955395
Study Brief:
Protocol Section:
NCT01955395