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Quality of Life in Patients With 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: NCT05136807
Recruitment Status : Recruiting
First Posted : November 29, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This study examines the quality of life in patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma. Collecting quality of life information from patients may help doctors learn more about the most common symptoms and concerns patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma may have.

Condition or disease Intervention/treatment
Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVE:

I. Describe baseline and follow up quality of life and monoclonal gammopathy of unknown significance/smoldering multiple myeloma (MGUS/SMM) related anxiety of patients with MGUS/SMM already participating in clinical trials at MD Anderson Cancer Center.

SECONDARY OBJECTIVE:

I. Identify the most common symptoms/patients concerns to evaluate future interventions for treatment/prevention in this population.

OUTLINE:

Patients complete quality of life questionnaires over 10-15 minutes at baseline and every 6 months for patients participating in an observational study or every month for patients participating in a treatment study for up to 3 years.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
Actual Study Start Date : June 7, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
Observational (quality of life questionnaire)
Patients complete quality of life questionnaires over 10-15 minutes at baseline and every 6 months for patients participating in an observational study or every month for patients participating in a treatment study for up to 3 years.
Other: Quality-of-Life Assessment
Complete questionnaires
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Quality of life questionnaires [ Time Frame: Up to 3 years ]

    Patients complete quality of life questionnaires over 10-15 minutes at baseline.

    Score scale ranges from (1-4) 1 - Not at all and 4 - Almost all the time


  2. Quality of life questionnaires [ Time Frame: Up to 3 years ]

    Patients complete quality of life questionnaires every 6 months for patients participating in an observational study or every month for patients participating in a treatment study for up to 3 years.

    Score scale ranges from (1-4) 1 - Not at all and 4 - Almost all the time




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
Patients with monoclonal gammopathy of unknown significance or smoldering multiple myeloma at MD Anderson Cancer Center
Criteria

Inclusion Criteria:

  • Patients with either 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
  • OR 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
  • Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center, including protocols PA15-0575 (NCT02726750) (Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies); 2015-0148 (Phase II single arm trial of Isatuximab in patients with intermediate and high risk smoldering multiple myeloma); and 2015-0371 (NCT02603887) (Pilot single arm, single center, open label trial of Pembrolizumab in patients with intermediate and high risk smoldering multiple myeloma) and any future clinical trials for MGUS and/or SMM that open at MD Anderson Cancer Center.
  • Only patients who are English or Spanish speaking are eligible.

Exclusion Criteria:

  • 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, United Kingdom [UK])
    • >1 focal lesions on magnetic resonance imaging (MRI) studies, if the patient has an MRI done per eligibility criteria (each focal lesion must be 5 mm or more in size)
  • Plasma cell leukemia.
  • Presence of cognitive impairment or delirium as determined by the primary clinician.

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): NCT05136807


Contacts
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Contact: Mei Huang 713-745-9901 mhuang3@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mei Huang    713-745-9901    mhuang3@mdanderson.org   
Principal Investigator: Elisabet E. Manasanch         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elisabet E Manasanch M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05136807    
Other Study ID Numbers: 2016-0172
NCI-2021-11118 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0172 ( Other Identifier: M D Anderson Cancer Center )
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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