NCT07202078 Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)
| NCT ID | NCT07202078 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Monash University |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-05-07 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 900 participants in total. It began in 2025-05-07 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services. This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial. The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.
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.
Contact & Investigator
Zoe McQuilten, Professor
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT07202078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07202078 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07202078 currently recruiting?
Yes, NCT07202078 is actively recruiting participants. Visit ClinicalTrials.gov or contact Monash University to inquire about joining.
Where is the NCT07202078 trial being conducted?
This trial is being conducted at Adelaide, Australia, Melbourne, Australia, Melbourne, Australia.
Who is sponsoring the NCT07202078 clinical trial?
NCT07202078 is sponsored by Monash University. The principal investigator is Zoe McQuilten, Professor at Monash University. The trial plans to enroll 900 participants.