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New treatment option for Myeloma
Official title Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
ClinicalTrials.gov ID: NCT07202091
What this study is testing
What is Trimethoprim Sulfamethoxazole?
Trimethoprim Sulfamethoxazole is an investigational medicine, given as an once-daily, being studied as a potential treatment for myeloma.
Also referred to as Co-Trimoxazole.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at...
- Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
- Patient is willing and able to comply with each of the treatment arms.
You likely can't join if
- 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.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal...
- Intolerance of all trial antibiotic options in either arm A or arm B.
- Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain...
- Pregnant or breastfeeding.
See the full eligibility criteria
- Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
- Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
- Patient is willing and able to comply with each of the treatment arms.
- 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.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Intolerance of all trial antibiotic options in either arm A or arm B.
- Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.
- 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 interests of the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.