Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Quality of life questionnaires
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Quality of life questionnaires
时间窗: 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
次要结局
未报告次要终点