NCT06048250 · City of Hope Medical Center
Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma
What this study is about
This phase I trial studies the safety, side effects, best dose and effectiveness of mezigdomide (CC-92480) when given after idecabtagene vicleucel (Abecma chimeric antigen receptor \[CAR\] T-cell therapy) in patients with multiple myeloma that has come back after a period of improvement (relapsed).
View original scientific description
This phase I trial studies the safety, side effects, best dose and effectiveness of mezigdomide (CC-92480) when given after idecabtagene vicleucel (Abecma chimeric antigen receptor \[CAR\] T-cell therapy) in patients with multiple myeloma that has come back after a period of improvement (relapsed). CC-92480 works by binding to a protein called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death in multiple myeloma cells. Giving mezigdomide after Abecma CAR T cell therapy may extending the amount of time that the CAR T cells persist in the body in patients with relapsed multiple myeloma.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
PROCEDURE
Computed Tomography
Undergo CT
BIOLOGICAL
Mezigdomide
Receive PO
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
Primary outcome measures
Incidence of adverse events
Time frame: Up to 2 years
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0). Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations