Phase 1 Myeloma Trial, Recruiting NCT05137054 Sponsor: Regeneron Pharmaceuticals Condition: Myeloma
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Phase 1 Myeloma Trial, Recruiting

NCT05137054
Recruiting Phase 1

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 who are relatively well and able to carry out daily activities with little to no limitation (as measured by a standard health scale used in cancer research)
  • People whose multiple myeloma can be measured and tracked using standard methods agreed upon by international myeloma experts
  • People whose kidneys, blood counts, and liver are functioning at an adequate level (as defined by the trial)
  • People with a life expectancy of at least 6 months
  • People with relapsed or treatment-resistant multiple myeloma (meaning the cancer came back or stopped responding to treatment) who have received at least 3 previous lines of treatment — or at least 2 previous lines under certain conditions — including specific types of myeloma drugs (confirm with trial site for exact requirements for each group)
  • For some groups in the trial: people whose myeloma has stopped responding to three different classes of drugs, including a type that targets a protein called CD38, an immunomodulatory drug, and a proteasome inhibitor
  • For some groups: people who have a visible tumour outside the bone marrow measuring at least 2 cm, if their myeloma cannot be measured through standard blood or urine tests

Who may not be able to join:

  • People diagnosed with certain related but different blood or plasma cell conditions, including plasma cell leukaemia, primary light-chain amyloidosis (not related to myeloma), Waldenström's macroglobulinaemia, or POEMS syndrome
  • People whose myeloma has spread to the brain or the membranes surrounding the brain or spinal cord
  • People who have received any systemic myeloma treatment very recently before the trial starts (within a timeframe defined by the trial)
  • People with certain histories of stem cell transplantation, as described in the trial protocol (confirm with trial site)
  • People who have previously been treated with certain immune-based therapies targeting a protein called BCMA — specifically T-cell engaging bispecific antibodies or CAR T-cell therapies targeting BCMA — unless a specific exception applies for their group
  • People with a history of a serious brain condition called progressive multifocal leukoencephalopathy, a degenerative neurological condition, a movement disorder affecting the nervous system, or a seizure within the past 12 months
  • People who have received a live or weakened vaccine capable of replicating within 28 days before starting the trial
  • People whose heart pumping function is below 40%, as measured by a heart scan
  • For one group: people who have previously been treated with a type of immune therapy targeting a protein called LAG-3, or who have an active autoimmune disease requiring ongoing immune-suppressing medication, or who have had a solid organ transplant, or who have had a severe immune reaction (grade 3 or higher) to a previous checkpoint inhibitor therapy
  • For another group: people who have previously been treated with therapies targeting PD-1 or PD-L1, or who had brain inflammation (encephalitis or meningitis) in the past year, or who have a history of certain lung conditions including interstitial lung disease or pneumonitis within the past 5 years, or who have had a solid organ transplant, or who have an active autoimmune disease requiring immune-suppressing treatment within the past 2 years, or who have had a severe immune reaction to a previous checkpoint inhibitor therapy
  • For one group: people with an abnormal heart rhythm measurement on an ECG, people taking certain heart rhythm or other medications known to affect heart electrical activity, people taking strong medications or consuming foods known to significantly affect how a specific study drug is processed by the body, or people with digestive conditions that may prevent proper absorption of a study drug
  • For one group: people with a known or suspected active Epstein-Barr virus infection, people with a history of a serious immune overreaction condition called haemophagocytic lymphohistiocytosis or macrophage activation syndrome, or people previously treated with a specific therapy targeting a protein called FcRH5
  • For the group receiving a drug called carfilzomib: people who previously had CAR T-cell therapy targeting BCMA may still be eligible if that treatment was completed at least 12 weeks before starting the trial (confirm with trial site)
  • For groups receiving lenalidomide or pomalidomide: people with a known condition affecting how the gut absorbs medication, or who would need the medication delivered through a feeding tube
  • For the group receiving bortezomib: people with nerve damage or numbness rated at a moderate or higher level of severity

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 28 July 2026
Phase 1: approximately ~10% 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

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
17 August 2022
Est. completion
25 March 2028

Where this trial is recruiting

🇫🇷 France 🇬🇷 Greece 🇮🇱 Israel 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period; Incidence of Treatment-Emergent Adverse Events (TEAEs); Severity of TEAEs; Incidence of Serious Adverse Events (SAEs); Severity of SAEs; Incidence of Adverse Events of Special Interest (AESIs); Severity of AESIs; Incidence of laboratory abnormalities

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: 28 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