Monoclonal Gammopathy of Undetermined SignificanceNCT02726750
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
An observational study of Monoclonal Gammopathy of Undetermined Significance and Smoldering Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Plasma Cell Myeloma
- What is being tested?
- Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2015to 30 Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with monoclonal gammopathy of unknown significance and/or smoldering multiple myeloma
Who may be able to join
- Patients with monoclonal gammopathy of unknown significance. Both criteria must be met:
- Serum monoclonal protein < 3 g/dL or urinary monoclonal protein < 500 mg per 24 hours and clonal bone marrow plasma cells < 10%
- Absence of myeloma defining events or amyloidosis
- Patients with smoldering multiple myeloma. Both criteria must be met:
- Serum monoclonal protein >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
- Absence of myeloma defining events or amyloidosis
Who cannot join
- Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following
- Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)
- Renal Insufficiency: creatinine clearance < 40 ml/min or serum creatinine > 2 mg/dL
- Anemia: hemoglobin value < 10 g/dL or 2 g/dL < normal reference
- Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT)
- Clonal bone marrow plasma cell percentage >= 60%
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- Involved:uninvolved serum free light chain ratio >= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom [UK])
- > 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size)
- Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies
- Bisphosphonates are permitted
- Radiotherapy is not permitted
- Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted
- Plasma cell leukemia
- Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Mei Huang, 713-745-9901, mhuang3@mdanderson.org
Krina Patel, MD
About this study
Official title: Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the rate of progression to multiple myeloma after 3 years of follow up.
SECONDARY OBJECTIVES:
- To describe baseline patient characteristics and clinical variables. II. To identify molecular and genetic correlates that may predict for progression to multiple myeloma (MM).
OUTLINE:
Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, positron emission tomography (PET)/computed tomography (CT) scans, and/or magnetic resonance imaging (MRI) scans to check the status of disease at the discretion of the treating physician.
After completion of 3 years on study, patients are followed up every 6-12 months thereafter.
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection) | Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, PET/CT scans, and/or MRI scans to check the status of disease at the discretion of the treating physician. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression to multiple myeloma (MM)
Kaplan-Meier method will be used to estimate time to MM progression. Log-rank test will be used to evaluate the difference in rate of progression between/among patient groups.
Measured: 3 years
Progression free survival
Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of progression free survival between/among patient groups.
Measured: 3 years
Overall survival
Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of overall survival between/among patient groups.
Measured: 3 years
Secondary outcomes (2)
Baseline patient characteristics and clinical variables
Summary statistics including mean, standard deviation, median, and range will be provided for continuous variables. Frequency counts and percentages will be used to summarize categorical variables.
Measured: Baseline
Molecular and genetic profile analysis
Will study the correlation of molecular and genetic profiles with time to MM progression.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start14 Dec 2015
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Krin Patel, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726750
- Sponsor's protocol ID
- PA15-0575
- Other IDs
- NCI-2020-07336, PA15-0575
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No