Quality of Life Assessment for Monoclonal Gammopathy

Overseen By Melody Becnel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Myeloma, Hypercalcemia, Renal insufficiency, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about the quality of life for people with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM), conditions where abnormal proteins are found in the blood without immediate symptoms. Participants will complete questionnaires about their daily experiences to help doctors understand common symptoms and concerns. The trial seeks individuals diagnosed with MGUS or SMM who are currently enrolled in specific clinical trials at MD Anderson Cancer Center and can speak English or Spanish. As an unphased study, this trial offers participants the chance to provide valuable insights into living with MGUS or SMM, potentially improving future care and support.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding the quality of life in patients with asymptomatic monoclonal gammopathies, a condition that often doesn't require immediate treatment. Unlike standard care, which typically involves monitoring and managing symptoms if they arise, this trial uses quality-of-life assessments to gather detailed patient experiences over time. By regularly administering questionnaires, the study aims to uncover insights into how these patients feel day-to-day, potentially leading to improved support strategies. This approach could help tailor future treatments to enhance patient well-being even before symptoms develop.

Who Is on the Research Team?

Melody E Becnel

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Serum monoclonal protein >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete quality of life questionnaires at baseline

1 day

1 visit (in-person or virtual)

Follow-up

Participants complete quality of life questionnaires every 6 months for observational study participants or every month for treatment study participants

Up to 3 years

Biannual or monthly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Quality-of-Life Assessment
• Questionnaire Administration

How Is the Trial Designed?

Group I: Observational (quality of life questionnaire) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+