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 |
|---|---|---|---|
| Flinders Medical Centre | Adelaide | Australia | Recruiting |
| Box Hill Hospital | Box Hill | Australia | Recruiting |
| Canberra Hospital | Canberra | Australia | Recruiting |
| Barwon Health, University Hospital Geelong | Geelong | Australia | Recruiting |
| Austin Hospital | Heidelberg | Australia | Recruiting |
| Nepean Cancer Centre | Kingswood | Australia | Recruiting |
| Northern Hospital | Melbourne | Australia | Recruiting |
| Sunshine Coast Health | Sunshine Coast | Australia | 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 have confirmed diagnosis of symptomatic MM per IMWG criteria.
2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
3. Participants must have measurable disease as defined in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Participants must have clinical laboratory values within a prespecified range.
Exclusion Criteria:
1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
2. Participants who defer transplant due to personal preference.
3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
* focal radiation and/or
* a short course of corticosteroids as defined in the protocol.
5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1.
7. Participants who have uncontrolled intercurrent illness.
8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
NOTE Other protocol defined inclusion/exclusion criteria apply.
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: 25 March 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.