Phase 3 study for people with Myeloma
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Research Site | Concord | NSW | Not yet recruiting |
| Research Site | Darlinghurst | NSW | Not yet recruiting |
| Research Site | East Melbourne | VIC | Not yet recruiting |
| Research Site | Fitzroy | Australia | Recruiting |
| Research Site | Liverpool | NSW | Not yet recruiting |
| Research Site | Melbourne | VIC | Not yet recruiting |
| Research Site | Murdoch | WA | Not yet recruiting |
| Research Site | Waratah | NSW | Not yet 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:
1. Participants must be 18 years or older, at the time of signing the ICF.
2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
6. ECOG performance status Grade of 0 to 2.
7. Participant must have adequate organ and bone marrow function.
EXCLUSION CRITERIA:
1. Participant has active or prior CNS or meningeal involvement of MM.
2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
7. Participant is positive for any of the following:
1. HIV: Known to be seropositive for HIV (including any history of HIV).
2. Chronic or active hepatitis B.
3. Active hepatitis C: Hepatitis C infection.
4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
8. Participant has clinically significant cardiovascular disease.
9. Participant has COPD with an FEV1 \< 50% of predicted normal.
10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.
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: 14 August 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.