Phase 3 Myeloma Trial, Recruiting NCT05730036 Sponsor: Regeneron Pharmaceuticals Condition: Myeloma
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Phase 3 Myeloma Trial, Recruiting

NCT05730036
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:

  • Adults aged 18 or older (or the legal age of an adult in their country) at the time of the first screening visit
  • People whose general health and ability to carry out daily activities meets a certain minimum level — those with a score of 0 or 1 on a standard medical scale, or possibly a score of 2 if the only reason for reduced function is pain or other local symptoms from their myeloma (confirm with trial site)
  • People who have received between 1 and 4 previous treatment regimens for multiple myeloma, including the drugs lenalidomide and a proteasome inhibitor, and whose myeloma has come back or stopped responding after their most recent treatment — with additional requirements depending on country (for example, people in Israel, the EU, and the UK must also have previously received a specific type of drug called a CD38 antibody; confirm specific country requirements with trial site)
  • People whose myeloma can be measured through standard tests, so that any response to treatment can be tracked
  • People whose blood counts, liver, kidneys, heart, and calcium levels are within acceptable ranges within 7 days before being assigned to a treatment group
  • People with a life expectancy of at least 6 months

Who may not be able to join:

  • People diagnosed with plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome
  • People who have previously been treated with the drugs elotuzumab or pomalidomide
  • People who have myeloma that has spread to the brain or the lining around the brain or spinal cord
  • People who have received any systemic cancer treatment within either 28 days or 5 half-lives of the study drug (whichever period is shorter) before starting the trial
  • People who have had an allogeneic (donor) stem cell transplant within the past 6 months, or a stem cell transplant using their own cells within the past 12 weeks before starting the trial — and those who have had a donor transplant must also have been off all immune-suppressing medications for at least 6 weeks with no signs of graft-versus-host disease
  • People who have previously received certain treatments that specifically target a protein called BCMA (note: a particular type of BCMA-targeting drug called an antibody-drug conjugate is allowed — confirm with trial site)
  • People with a history of, or known or suspected, a serious brain condition called progressive multifocal leukoencephalopathy (PML), or a history of certain nervous system or movement disorders such as Parkinson's disease
  • People who have had an infection serious enough to require hospitalisation or intravenous (drip) antibiotics or antiviral treatment within 2 weeks before starting the trial
  • People with an uncontrolled HIV, hepatitis B, or hepatitis C infection, or any other uncontrolled infection (confirm definition with trial site)
  • People whose heart pumping function (ejection fraction) is below 40%

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 13 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: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

Australian sites

Royal Prince Alfred Hospital, Camperdown, New South Wales
Royal North Shore Hospital, St Leonards, New South Wales
Icon Cancer Centre - Wesley, Auchenflower, Queensland
Royal Brisbane and Women's Hospital, Herston, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
Royal Hobart Hospital, Hobart, Tasmania
Launceston General Hospital, Launceston, Tasmania
St Vincent's Hospital, Fitzroy, Victoria
University Hospital Geelong, Geelong, Victoria
Austin Hospital, Heidelberg, Victoria
One Clinical Research at Hollywood Private Hospital, Nedlands, Western Australia

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
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
18 September 2023
Est. completion
19 April 2033

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants

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: 13 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