Biomarker Analysis for Multiple Myeloma

Overseen By Mei Huang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Investigational agents

Disqualifiers: Myeloma, Renal insufficiency, Anemia, others

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

Compensation: Varies

Number of Visits: 7

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some individuals with certain blood conditions, such as monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM), develop multiple myeloma while others do not. Researchers examine various markers, including protein levels in the blood and bone changes, to identify patterns that might predict disease progression. Participants will have their blood collected every six months for three years and may undergo additional tests like biopsies or scans. This trial suits those with MGUS or SMM who have no symptoms or significant complications. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance understanding and early detection of disease progression.

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

The trial does not specify if you need to stop your current medications, but it does allow the use of bisphosphonates. Radiotherapy and prior chemotherapy for asymptomatic gammopathies are not allowed.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand the progression of monoclonal gammopathies, like MGUS and smoldering myeloma, which can lead to multiple myeloma. Unlike treatments that focus on managing symptoms, this observational approach collects biospecimens like blood samples and may include imaging scans to closely monitor changes over time. By doing so, researchers hope to uncover early indicators of disease progression, which could lead to earlier and more targeted interventions in the future. This proactive monitoring could revolutionize how we predict and manage the transition to multiple myeloma, potentially improving patient outcomes.

Who Is on the Research Team?

Krin Patel, MD

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 clonal bone marrow plasma cells < 10%

Absence of myeloma defining events or amyloidosis

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo collection of blood samples every 6 months for 3 years. Additional tests such as biopsy, x-rays, PET/CT scans, and MRI scans may be conducted at the discretion of the treating physician.

3 years

6 visits (in-person) over 3 years

Follow-up

Participants are monitored every 6-12 months after the initial 3-year observation period to assess progression to multiple myeloma.

Ongoing

1-2 visits per year (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection

How Is the Trial Designed?

Group I: Observational (biospecimen collection) Experimental Treatment 2 Interventions

Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, PET/CT scans, and/or MRI scans to check the status of disease at the discretion of the treating physician.

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+