MyelomaPhase 2/3NCT07202065
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)
A Phase 2/3 study testing Immune Globulin Intravenous in people with Myeloma and Non Hodgkin's Lymphoma, run by Monash University at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Non Hodgkin's Lymphoma, Leukemia
- What is being tested?
- Immune Globulin Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesAustralia
- Study dates
- 28 Apr 2025to 31 Mar 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
- Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Who cannot join
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment.
- Previous splenectomy.
- Known history of bronchiectasis.
- Previous participation in this domain.
- Treating team deems enrolment in the domain is not in the best interest of the patient.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter Bardy, Dr, +61 (8) 7074 5898, peter.bardy@sa.gov.au
Chris Hoare, +61 08 7074 3290, christine.hoare@sa.gov.au
- Recruiting
Austin Hospital
Melbourne, Victoria, 3004
Andrew Lim, Dr, +61 (03) 9070 5741, andrew.lim@austin.org.au
Selena Squillaciotti, Selena.SQUILLACIOTI@austin.org.au
- Recruiting
Northern Health
Melbourne, Victoria, 3004
Rachel Cooke, PhD, +61 (03) 8408 6000, rachel.cooke@nh.org.au
Rhiannon Davidson, rhiannon.davidson@nh.org.au
About this study
Official title: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)
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.
Read the detailed description
This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.
- Conditions
- Myeloma, Non Hodgkin's Lymphoma, Leukemia
- Being tested
- Immune Globulin Intravenous
- Keywords
- immunoglobulin, antibiotics, myeloma, leukaemia, lymphoma, non Hodgkins, infection, infections, blood, cancer, haematology
- Medical subject headings
- Neoplasms, Plasma Cell, Leukemia, Lymphoma, Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin IntravenousBiological
Also called IVIG
Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Low dose (IgRT) immunoglobulin replacement therapy | Other | Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum (IgG) immunoglobulin G levels is required. Receives: Biological: Immune Globulin Intravenous |
| Arm B: Usual dose | Other | Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum (IgG) immunoglobulin G reference range. Receives: Biological: Immune Globulin Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS).
Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)
Secondary outcomes (14)
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of microbiologically documented infections from randomisation to 12 months.
Number of microbiologically documented infections from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
All-cause mortality at 12 months.
All-cause mortality at 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Infection-related mortality at 12 months.
Infection-related mortality at 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.
Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more treatment-related adverse events.
Occurrence of one or more treatment-related adverse events.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of treatment-related adverse events.
Number of treatment-related adverse events.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.
Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.
Measured: Randomisation, Month 3, Month 6, Month 9 and Month 12
Costs associated with allocated treatment arm and infections during study.
Costs of infections and trial interventions will be estimated based on trial treatment and adverse event data within the hospital medical record, as well as linked data obtained from the Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Register (AIR). Data from the quality of life questionnaires will be used to calculate quality adjusted life years.
Measured: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start28 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Up to 900 participants will be recruited to the RATIONAL-PT, including up to 300 per domain. The aim of the platform is to determine optimal supportive care interventions for patients with haematological malignancies. The primary outcome for the platform is Event-free survival (EFS), defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause. Data from each domain will contribute to the primary analysis.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoe McQuilten, Professor, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202065
- Sponsor's protocol ID
- TRU-RPT-22 Dose-Ig
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available. Data will only be presented as a whole, no individual data will be published or presented.