Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma

NCT06048250 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 22143NCI-2023-06771P30CA033572
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  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.

  Up to 2 years

Secondary Outcomes (6)

• Overall response rate

  Up to 2 years

• Complete response rate

  Up to 2 years

• Overall survival

  From first day of treatment to time of death due to any cause, assessed up to 2 years

• Progression free survival

  From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 2 years

• Time to progression

  From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 2 years

Study Arms (1)

Treatment (mezigdomide)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Computed Tomography; Biological: Mezigdomide; Procedure: Positron Emission Tomography

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (mezigdomide)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Treatment (mezigdomide)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (mezigdomide)

Mezigdomide BIOLOGICAL

Receive PO

Also known as: BMS 986348, BMS-986348, BMS986348, CC 92480, CC-92480, CELMoD CC-92480, Cereblon E3 Ligase Modulation Drug CC-92480, Cereblon E3 Ubiquitin Ligase Modulating Agent CC-92480, Cereblon Modulator CC-92480

Treatment (mezigdomide)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (mezigdomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Murali Janakiram

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: April 9, 2024
• Primary Completion: March 21, 2026
• Study Completion: March 21, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)