- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06048250
Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma
A Phase 1 Study of Mezigdomide (CC-92480) and Dexamethasone Post Idecabtagene Vicleucel in Relapsed Multiple Myeloma
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of mezigdomide (CC-92480) given post idecabtagene vicleucel when administered as a continued therapy.
SECONDARY OBJECTIVES:
I. To evaluate the anti-tumor activity of mezigdomide (CC-92480) when administered post idecabtagene vicleucel.
II. To determine the persistence of CAR T cells at day 90 (D90), day 180 (D180), and day 365 (D365) after start of mezigdomide (CC-92480) therapy.
EXPLORATORY OBJECTIVES:
I. To assess levels of serum BCMA monthly at day 1 of every cycle. II. To assess the effects of mezigdomide (CC-92480) on non-cancer immune cells in the peripheral blood and bone marrow samples.
OUTLINE: This is a dose-escalation study of mezigdomide.
Starting between 30 and 90 days after infusion of idecabtagene vicleucel, patients receive mezigdomide orally (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 positron emission tomography (PET)/computed tomography (CT) during screening. Patients also undergo bone marrow aspiration and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, every 3 months within 1 year of start of treatment, and then every 6 months until progression or for up to 2 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Duarte, California, United States, 91010
- Recruiting
- City of Hope Medical Center
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Contact:
- Murali Janakiram
- Phone Number: 85200 626-256-4673
- Email: MJANAKIRAM@COH.ORG
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Principal Investigator:
- Murali Janakiram
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET/CT
Other Names:
Undergo bone marrow aspiration
Receive PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to 2 years
|
Will be defined as the proportion of subjects with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR), or partial response (PR), as determined by the investigator according to standard International Myeloma Working Group (IMWG) response criteria.
|
Up to 2 years
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Complete response rate
Time Frame: Up to 2 years
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Will be defined as the proportion of patients meeting the criteria CR or sCR.
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Up to 2 years
|
Overall survival
Time Frame: From first day of treatment to time of death due to any cause, assessed up to 2 years
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From first day of treatment to time of death due to any cause, assessed up to 2 years
|
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Progression free survival
Time Frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 2 years
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Will be determined by the investigator according to standard IMWG response criteria.
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From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 2 years
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Time to progression
Time Frame: From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 2 years
|
From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 2 years
|
|
Duration of response
Time Frame: From first response documented until disease progression, assessed up to 2 years
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Will be determined by the investigator according to standard IMWG response criteria.
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From first response documented until disease progression, assessed up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Murali Janakiram, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 22143 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2023-06771 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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