Phase 2 study for people with Myeloma
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Westmead Hospital /ID# 255200 | Westmead | NSW | Recruiting |
| Princess Alexandra Hospital /ID# 255202 | Woolloongabba | QLD | Recruiting |
| Box Hill Hospital /ID# 255199 | Box Hill | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
* Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2.
* Have at least 1 organ historically impacted by AL amyloidosis.
* Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy.
* Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Exclusion Criteria:
* Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class.
* Participant has the following conditions:
* Other non-AL amyloid disease;
* Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium \> 11 mg/dL);
* Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential);
* Waldenström's macroglobulinemia;
* Acute diffuse infiltrative pneumopathy;
* Major surgery within 28 days prior first dose or planned during study participation;
* History of organ transplant requiring continued use of immunosuppressants;
* Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
* Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 May 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.