Preventing infections in people with blood cancers using antibiotics or immunoglobulin

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Start Ig)

This project tests whether giving regular intravenous immunoglobulin or prophylactic antibiotics better prevents infections in people with myeloma, non-Hodgkin lymphoma, or leukemia who have not yet started immunoglobulin replacement.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Monash University (Academic / other)
• Locations: 3 sites (Adelaide, South Australia and 2 other locations)
• Trial ID: NCT07202078 on ClinicalTrials.gov

What this trial studies

This domain of the adaptive RATIONAL platform trial randomizes patients with blood cancers who are not on Ig replacement to receive either prophylactic antibiotics (trimethoprim–sulfamethoxazole) or intravenous immunoglobulin (IVIG). The trial uses an adaptive platform design to compare multiple prevention strategies concurrently, update analyses as data accrue, and add new questions over time. Primary outcomes focus on infection rates, safety, and healthcare utilization across participating Australian centers. The study spans phases 2 and 3 to capture both initial efficacy/safety signals and confirmatory outcomes.

Who should consider this trial

Good fit: Adults with myeloma, non-Hodgkin lymphoma, or leukemia who are not currently receiving immunoglobulin replacement and who meet safety criteria (e.g., not pregnant, adequate renal function) are ideal candidates.

Not a fit: Patients already on Ig replacement, those with IgA deficiency with anti-IgA, prior splenectomy, severe renal impairment, current need for systemic antibiotics, or pregnant/breastfeeding individuals are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the result could reduce infections and hospital visits and may provide a more accessible or lower-cost alternative to routine immunoglobulin infusions.

How similar studies have performed: IVIG has shown benefit for infection prevention in selected antibody-deficient patients, whereas direct head-to-head platform comparisons between IVIG and routine antibiotic prophylaxis are limited, so this approach is partly novel.

Eligibility criteria

Inclusion Criteria:

* None.

Exclusion Criteria:

1. Prior or planned allogeneic haematopoietic stem cell transplantation.
2. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
3. Received immunoglobulin replacement in the preceding three months.
4. Objection to receiving immunoglobulin products.
5. Known history of IgA deficiency with anti-IgA.
6. History of severe allergy to immunoglobulin products.
7. Current active infection requiring systemic antibiotics.
8. Allergy or intolerance of all domain antibiotic options.
9. Pregnant or breastfeeding.
10. Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
11. Previous splenectomy.
12. Previous participation in this domain.
13. Treating team deems enrolment in the domain is not in the best interest of the patient.

Where this trial is running

Adelaide, South Australia and 2 other locations

• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Austin Hospital — Melbourne, Victoria, Australia (Recruiting)
• Northern Health — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Zoe McQuilten, Professor — Monash University

Conditions Myeloma; Non Hodgkin' s Lymphoma; Leukemia; immunoglobulin; antibiotics; myeloma; leukaemia