MyelomaPhase 2/3NCT07202078
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)
A Phase 2/3 study testing Trimethoprim / Sulfamethoxazole and 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?
- Trimethoprim / Sulfamethoxazole and 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
- 7 May 2025to 31 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- None.
Who cannot join
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Received immunoglobulin replacement in the preceding three months.
- Objection to receiving immunoglobulin products.
- Known history of IgA deficiency with anti-IgA.
- History of severe allergy to immunoglobulin products.
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- Current active infection requiring systemic antibiotics.
- Allergy or intolerance of all domain antibiotic options.
- Pregnant or breastfeeding.
- Severe renal impairment (estimated or measured creatinine clearance of < 30 mL/min).
- Previous splenectomy.
- 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 (Start 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
- Trimethoprim / Sulfamethoxazole, 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.
Trimethoprim / SulfamethoxazoleDrug
Also called Co-Trimoxazole
Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
Immune Globulin IntravenousBiological
Also called Immune Globulin Subcutaneous
IVIg 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 reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Start prophylactic oral antibiotics | Other | Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. Receives: Drug: Trimethoprim / Sulfamethoxazole |
| Arm B: Start immunoglobulin replacement | Other | IVIg 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 reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required. 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 start7 May 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
- NCT07202078
- Sponsor's protocol ID
- TRU-RPT-22 Start-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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Start Ig)
- ClinicalTrials.gov ID
- NCT07202078
- Acronym / sponsor ID
- TRU-RPT-22 Start-Ig
- Conditions
- Myeloma, Non Hodgkin's Lymphoma, Leukemia
- Keywords
- immunoglobulin, antibiotics, myeloma, leukaemia, lymphoma, non Hodgkins, infection, infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Start prophylactic oral antibiotics | Other | Drug: Trimethoprim / SulfamethoxazoleOnce daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. |
| Arm B: Start immunoglobulin replacement | Other | Biological: Immune Globulin IntravenousIVIg 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 reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- None.
Key exclusion criteria (13 listed)
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Received immunoglobulin replacement in the preceding three months.
- Objection to receiving immunoglobulin products.
- Known history of IgA deficiency with anti-IgA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim / SulfamethoxazoleAlso: Co-TrimoxazoleOnce daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. | Drug | Arm A: Start prophylactic oral antibiotics |
| Immune Globulin IntravenousAlso: Immune Globulin SubcutaneousIVIg 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 reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required. | Biological | Arm B: Start immunoglobulin replacement |
Primary outcome
Event-free survival (EFS).
Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
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.
14 secondary outcomes
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
All-cause mortality at 12 months.
Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Infection-related mortality at 12 months.
Time frame: 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 frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more treatment-related adverse events.
Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of treatment-related adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Randomisation, Month 3, Month 6, Month 9 and Month 12.
Costs associated with allocated treatment arm and infections during study.
Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoe McQuilten, Professor principal investigator
Monash University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trimethoprim / Sulfamethoxazole and Immune Globulin Intravenous in people with Myeloma and Non Hodgkin's Lymphoma, run by Monash University at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS). (time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.