Phase 3 study for people with Myeloma
Not yet recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Research Site | Brisbane | QLD | Status not stated |
| Research Site | Camperdown | NSW | Status not stated |
| Research Site | Darlinghurst | NSW | Status not stated |
| Research Site | Fitzroy | Australia | Status not stated |
| Research Site | Melbourne | VIC | Status not stated |
| Research Site | Nedlands | WA | Status not stated |
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:
* ≥18 years of age.
* Documented diagnosis of NDMM according to IMWG diagnostic criteria.
* Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
* Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
* Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
* ECOG performance status score of 0 or 1.
* Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
* Adequate organ and bone marrow function.
Exclusion Criteria:
* Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
* Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
* Significant neurological or psychiatric condition
* Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
* Participants who required the introduction of an additional agent therapy due to inadequate response.
* Prior T-cell engager therapy directed at any target.
* Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
* Prior any therapy that is targeted to BCMA and CD19.
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: 30 July 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.