Phase 3 Myeloma Trial, Recruiting NCT05678621 Sponsor: Monash University Condition: Myeloma
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Phase 3 Myeloma Trial, Recruiting

NCT05678621
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older
  • People who have been diagnosed with chronic lymphocytic leukaemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL)
  • People who have been receiving immunoglobulin (Ig) therapy — given either through a drip or an injection under the skin — to prevent bacterial infections due to low antibody levels, for more than 6 months in a row
  • People whose treating doctor considers it appropriate to try stopping Ig therapy as part of this trial
  • People with a life expectancy of more than 12 months
  • People who are able to give informed consent and are willing and able to follow the requirements of both treatment arms in the trial

Who may not be able to join:

  • People who have had, or are planned to have, a stem cell transplant from a donor
  • People who have had a serious infection (graded as severe or higher) in the past 3 months, or who currently have an active infection being treated with antimicrobial medication
  • People who are already taking daily antibiotics specifically to prevent bacterial infections (note: preventive antiviral, antifungal, or PJP medications do not apply here)
  • People who cannot tolerate any of the antibiotic options offered in either arm of the trial
  • People for whom communication difficulties, compliance challenges, or practical barriers are likely to make it hard to take antibiotics as directed or to seek urgent medical attention if signs of infection develop
  • People who are pregnant or breastfeeding
  • People with severely reduced kidney function (creatinine clearance below 30 mL/min)
  • People who have had their spleen removed
  • People who have previously taken part in this trial
  • People whose treating medical team considers participation in the trial to not be in their best interests

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Prof Erica Wood, Monash University

Phone: +61 3 9903 0379

Australian sites

Canberra Hospital, Garran, Australian Capital Territory
Concord Hospital, Concord, New South Wales
Royal North Shore, St Leonards, New South Wales
Monash Medical Centre, Clayton, Victoria
Austin Hospital, Heidelberg, Victoria
The Alfred Hospital, Melbourne, Victoria
Sunshine Hospital, St Albans, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Monash University
Registry
ClinicalTrials.gov
Start date
30 November 2022
Est. completion
1 April 2027

Where this trial is recruiting

🇦🇺 Australia

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-free survival (EFS), defined as time from randomisation until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov