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Prospective Observational Study of Clinical and Genomic Predictors of Progression to Myeloma in Asymptomatic Monoclonal Gammopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726750
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Quest Diagnostics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to find markers that might help predict why some patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) develop multiple myeloma, while others do not.

Markers that will be studied may include participant's age, level of proteins in blood and urine, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities.


Condition or disease Intervention/treatment
Monoclonal Gammopathy of Unknown Significance Smoldering Multiple Myeloma Procedure: Blood Collection

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Clinical and Genomic Predictors of Progression to Myeloma in Asymptomatic Monoclonal Gammopathies
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Monoclonal Gammopathy of Unknown Significance (MGUS)
Participants with monoclonal gammopathy of unknown significance (MGUS) at MD Anderson Cancer Center.
Procedure: Blood Collection
Blood (about 1-2 tablespoons) collected for biomarker and routine tests and to check the status of the disease.
Other Name: Blood draw

Smoldering Multiple Myeloma (SMM)
Participants with smoldering multiple myeloma (SMM) at MD Anderson Cancer Center.
Procedure: Blood Collection
Blood (about 1-2 tablespoons) collected for biomarker and routine tests and to check the status of the disease.
Other Name: Blood draw




Primary Outcome Measures :
  1. Rate of Progression to Multiple Myeloma [ Time Frame: 3 years ]
    Kaplan-Meier method used to estimate the time-to-event endpoints.


Biospecimen Retention:   Samples With DNA
Blood (about 1-2 tablespoons) collected for biomarker testing every 6 months for 3 years.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with asymptomatic monoclonal gammopathies at MD Anderson Cancer Center in Houston, Texas
Criteria

Inclusion Criteria:

  1. Patients with monoclonal gammopathy of unknown significance age ≥ 18 years old.

    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
  2. Patients with smoldering multiple myeloma age ≥ 18 years old.

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

Exclusion Criteria:

  1. 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%
    • Involved:uninvolved serum free light chain ratio ≥100 measured by Freelite assay (The Binding Site Group, Birmingham, UK)
    • >1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
  2. 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
  3. Plasma cell leukemia
  4. Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726750


Contacts
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Contact: Elisabet E. Manasanch, MD 713-745-8092 EEManasanch@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Quest Diagnostics
Investigators
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Principal Investigator: Elisabet E. Manasanch, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02726750    
Other Study ID Numbers: PA15-0575
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Monoclonal gammopathy of unknown significance
MGUS
Smoldering multiple myeloma
SMM
Asymptomatic monoclonal gammopathies
Biomarker testing
Blood collection
Blood draw
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Precancerous Conditions