Recruiting
Phase 1

Mezigdomide

Sponsor:

City of Hope Medical Center

Code:

NCT06048250

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspiration

Computed Tomography

Mezigdomide

Positron Emission Tomography

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT06048250

Start date

Apr 9, 2024

Status verified date

Apr, 2026

Completion date

Sep 21, 2026

Anticipated

Primary completion date

Sep 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (mezigdomide)

Starting between 30 and 90 days after infusion of idecabtagene vicleucel, patients receive mezigdomide PO on days 1-21 or days 1-14 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT during screening. Patients also undergo bone marrow aspiration and blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspiration

Undergo bone marrow aspiration

Computed Tomography

Undergo CT

Mezigdomide

Receive PO

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Murali Janakiram

626-256-4673MJANAKIRAM@COH.ORG

Principal Investigator:

Murali Janakiram

More Information

Sponsor

City of Hope Medical Center

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-04-07.