Phase 3 study for people with Myeloma

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 14 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Regeneron Pharmaceuticals
Registry number NCT05730036
Started 18 September 2023 Today 16 October 2026 Estimated completion 19 April 2033

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Prince Alfred Hospital Camperdown NSW Active not recruiting
Royal North Shore Hospital St Leonards NSW Active not recruiting
Icon Cancer Centre - Wesley Auchenflower QLD Active not recruiting
Royal Brisbane and Women's Hospital Herston QLD Active not recruiting
Royal Adelaide Hospital Adelaide SA Active not recruiting
Royal Hobart Hospital Hobart TAS Active not recruiting
Launceston General Hospital Launceston TAS Active not recruiting
St Vincent's Hospital Fitzroy VIC Active not recruiting
University Hospital Geelong Geelong VIC Active not recruiting
Austin Hospital Heidelberg VIC Active not recruiting
One Clinical Research at Hollywood Private Hospital Nedlands WA Active not recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 14 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 410

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.

Key Inclusion Criteria:

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.

2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.

3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.

4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol

5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium

6. Life expectancy of at least 6 months

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).

2. Prior treatment with elotuzumab and/or pomalidomide

3. Participants with known MM brain lesions or meningeal involvement

4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter

5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.

6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.

7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).

8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug

9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Dates on the record

Started 18 September 2023
Estimated completion 19 April 2033
Registry last updated 7 October 2026
Checked by Voxsanity 14 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 October 2026.
  • This page last checked by Voxsanity: 14 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.