Rifaximin Versus No Intervention for the Treatment of IgA Monoclonal Gammopathy of Undetermined Significance

Conditions

• IgA Monoclonal Gammopathy of Undetermined Significance

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rifaximin — DRUG
  Given PO
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection

Study Details

This phase II trial compares the effect of rifaximin to no intervention for the treatment of IgA monoclonal gammopathy of undetermined significance (MGUS). Rifaximin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill cancer cells or precancerous cells like those found with MGUS. Giving rifaximin may kill more precancerous cells in patients with IgA MGUS.

Key Dates

Start date

Jan 22, 2026

Status verified

Apr 2026

Primary completion

May 1, 2028

Completion

May 1, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Rifaximin)
  Patients receive rifaximin orally (PO) three times daily (TID) for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
• Other: Arm B (No intervention)
  Patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Overall response rate [ Time Frame: From the start of therapy, up to 90 days ]

Central Contacts

• Madhav Dhodapkar, MBBS
  206-606-4888
  [email protected]

Locations (1)

Find similar trials in Seattle, WA