RECRUITING

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Quick Facts

Study Start:2016-06-07

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05136807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Melody Becnel, MD

CONTACT

832-206-9804

mrbecnel@mdanderson.org

Principal Investigator

Elisabet E Manasanch

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Elisabet E Manasanch, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06-07

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2016-06-07

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Monoclonal Gammopathy of Undetermined Significance
Smoldering Plasma Cell Myeloma