Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-11118 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0172 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Complete questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaires | 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 | Up to 3 years |
| Quality of life questionnaires | 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 | Up to 3 years |
Not provided
Not provided
Inclusion Criteria:
Patients with either monoclonal gammopathy of unknown significance age >= 18 years old.
Both criteria must be met:
OR Patients with smoldering multiple myeloma age >= 18 years old.
Both criteria must be met:
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
Plasma cell leukemia.
Presence of cognitive impairment or delirium as determined by the primary clinician.
Not provided
Not provided
Not provided
Patients with monoclonal gammopathy of unknown significance or smoldering multiple myeloma at MD Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melody Becnel, MD | Contact | 832-206-9804 | mrbecnel@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Melody E Becnel | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration | Other | Complete questionnaires |
|
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |