New combo aims to keep myeloma in check after CAR t
NCT ID NCT06048250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new pill, mezigdomide, given after CAR T-cell therapy (Abecma) in 15 adults with multiple myeloma that has returned. The goal is to see if the drug is safe and can help the CAR T cells last longer to better control the cancer. Participants must have tried at least four prior treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Diagnosis of multiple myeloma * Subject must have received at least 4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody * Receipt of commercially available idecabtagene vicleucel (Abecma) according to FDA approved US Prescribing Information. Note: Patients who received non-conforming Abecma who were originally prescribed Abecma according to the FDA approved label may be considered for inclusion per the investigators discretion. Subject must be between day 30 and day 90 post receipt of idecabtagene vicleucel * Subject must have experienced at least a stable disease in response to idecabtagene vicleucel * Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy, including idecabtagene vicleucel * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 without the use of filgrastim in the previous 3 days (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Platelets \>= 75,000/mm\^3 without platelet transfusion in the previous 3 days. (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has known Gilbert's disease) (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated). * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Aspartate aminotransferase (AST) =\< 3 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated). * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Alanine transaminase (ALT) =\< 3 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated). * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Alkaline phosphatase =\< 5 x ULN (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated). * Two repeat tests are allowed. If the repeat test satisfies criteria, the participant may enroll provided all other criteria are met * Oxygen saturation \> 92% on room air (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (To be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Agreement by females of childbearing potential and males to follow the guidelines of the mezigdomide (CC-92480) pregnancy prevention plan Exclusion Criteria: * Prior exposure to mezigdomide (CC-92480) * Current or planned use of other therapies other than mezigdomide (CC-92480) * Patients who are currently receiving or likely to require systemic immunosuppressive therapy. Physiologic replacement of steroids (=\< 5.0 mg/day prednisone or equivalent) is allowed * Concomitant use of CYP3A4/5 inhibitors and inducers * Concomitant use of proton pump inhibitors * Evidence of relapse as evaluated by the treating physician or study investigator * Active central nervous system involvement * Ongoing toxicities associated with cytokine release syndrome (CRS) or Immune effector cell-associated neurotoxicity syndrome (ICANS) from CAR T cell therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Coronavirus disease 2019 (COVID-19) positive, as assessed by a polymerase chain reaction (PCR) test or active uncontrolled infections (defined as active antibiotic use within 7 days of starting the investigational drug) * If human immunodeficiency virus (HIV) positive: CD4+ T cell count \< 200 * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?