400 Participants Needed

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

MH
MB
Overseen ByMelody Becnel, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ME

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
See 2 more

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?
1Treatment groups
Experimental Treatment
Group I: Observational (quality of life questionnaire)Experimental Treatment2 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.

Find a Clinic Near You

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+
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