Phase 2 Myeloma Trial, Recruiting NCT05828511 Sponsor: Regeneron Pharmaceuticals Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05828511
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard cancer health scale (called ECOG status 0, 1, or 2)
  • People who have been formally diagnosed with symptomatic Multiple Myeloma (MM) according to recognised international diagnostic guidelines
  • People whose myeloma can be measured and tracked to assess how it responds to treatment, based on standard international criteria
  • People who have not yet received any treatment for Multiple Myeloma, except for emergency or pain-relief radiation therapy, or up to one month of a single steroid medication (with appropriate time since last dose as set out in the protocol)
  • People whose bone marrow, liver, kidneys, and heart are functioning at an adequate level as defined in the study protocol
  • People who are under 70 years of age and whose liver, kidney, lung, and heart function meet the standards required to be considered suitable for a stem cell transplant, based on their treating institution's guidelines

Who may not be able to join:

  • People who are currently taking another experimental treatment known or suspected to work against Multiple Myeloma, or any treatment targeting a specific set of proteins involved in myeloma cell survival (the APRIL/TACI/BCMA pathway)
  • People who have Multiple Myeloma that has spread to the brain or central nervous system, a known or suspected brain condition called Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive or movement disorders affecting the brain or nervous system, or a seizure within the 12 months before enrolling in the study
  • People whose disease is progressing rapidly and urgently — for example, with worsening kidney failure or high calcium levels that are not responding to standard treatments — and who need chemotherapy right away
  • People diagnosed with certain related but distinct blood or plasma cell conditions, including non-secretory myeloma, active plasma cell leukaemia, primary light-chain (AL) amyloidosis, Waldenström macroglobulinaemia, or POEMS syndrome

Note: Additional eligibility criteria beyond those listed here are described in the full study protocol. The trial site will assess all criteria in detail.


Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
19 December 2023
Est. completion
2 November 2035

Where this trial is recruiting

🇫🇷 France 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Incidence of Dose-Limiting Toxicities (DLTs); Incidence of Treatment-Emergent Adverse Events (TEAEs); Severity of TEAEs; Incidence of Adverse Events of Special Interest (AESIs); Severity of AESIs; Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria; Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy; Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy;...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov