Multiple MyelomaPhase 1NCT06048250
Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma
A Phase 1 study testing Biospecimen Collection, Bone Marrow Aspiration and Computed Tomography in people with Multiple Myeloma, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to 21 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Murali Janakiram, 626-256-4673 ext. 85200, MJANAKIRAM@COH.ORG
Murali Janakiram
About this study
Official title: A Phase 1 Study of Mezigdomide (CC-92480) and Dexamethasone Post Idecabtagene Vicleucel in Relapsed Multiple Myeloma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and tolerability of mezigdomide (CC-92480) given post idecabtagene vicleucel when administered as a continued therapy.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Multiple Myeloma
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Computed Tomography, Mezigdomide, Positron Emission Tomography
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
MezigdomideBiological
Also called BMS 986348, BMS-986348, BMS986348, CC 92480
Receive PO
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Computed Tomography; Biological: Mezigdomide; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (6)
Overall response rate
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.
Measured: Up to 2 years
Complete response rate
Will be defined as the proportion of patients meeting the criteria CR or sCR.
Measured: Up to 2 years
Overall survival
Measured: From first day of treatment to time of death due to any cause, assessed up to 2 years
Progression free survival
Will be determined by the investigator according to standard IMWG response criteria.
Measured: 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
Measured: 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
Will be determined by the investigator according to standard IMWG response criteria.
Measured: From first response documented until disease progression, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Apr 2024
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Murali Janakiram, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048250
- Sponsor's protocol ID
- 22143
- Other IDs
- NCI-2023-06771, 22143, P30CA033572
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Mezigdomide (CC-92480) and Dexamethasone Post Idecabtagene Vicleucel in Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06048250
- Acronym / sponsor ID
- 22143
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and tolerability of mezigdomide (CC-92480) given post idecabtagene vicleucel when administered as a continued therapy.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (mezigdomide) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Computed Tomography, Biological: Mezigdomide, Procedure: Positron Emission TomographyStarting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (mezigdomide) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Treatment (mezigdomide) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (mezigdomide) |
| MezigdomideAlso: BMS 986348, BMS-986348, BMS986348, CC 92480Receive PO | Biological | Treatment (mezigdomide) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (mezigdomide) |
Primary outcome
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.
6 secondary outcomes
Overall response rate
Time frame: Up to 2 years
Complete response rate
Time frame: 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
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
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
Duration of response
Time frame: From first response documented until disease progression, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murali Janakiram principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biospecimen Collection, Bone Marrow Aspiration and Computed Tomography in people with Multiple Myeloma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.