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Mezigdomide After CAR T-cell Therapy for Multiple Myeloma

Phase 1

Recruiting

Led By Murali Janakiram

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have experienced at least a stable disease in response to idecabtagene vicleucel

Diagnosis of multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial studies if mezigdomide can extend how long Abecma CAR T-cells stay in the body to treat relapsed multiple myeloma.

Who is the study for?

This trial is for adults with relapsed multiple myeloma who've had at least four prior treatments, including specific agents like immunomodulatory drugs and proteasome inhibitors. They must have shown a stable disease response to CAR T-cell therapy (idecabtagene vicleucel), be in good health otherwise, and not pregnant or breastfeeding. Participants need normal organ function tests and can't be on certain other medications or have uncontrolled infections.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of Mezigdomide given after CAR T-cell therapy in patients with relapsed multiple myeloma. It will determine the best dose while monitoring how long the CAR T cells stay active post-treatment. The study includes various assessments like CT scans, PET scans, bone marrow aspirations, and biospecimen collection.See study design

What are the potential side effects?

Potential side effects of Mezigdomide may include changes in blood counts leading to increased infection risk or bleeding problems, liver issues reflected by altered lab tests, fatigue, allergic reactions similar to those from related compounds, digestive disturbances among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition has not worsened after receiving idecabtagene vicleucel treatment.

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I have been diagnosed with multiple myeloma.

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I've had 4 treatments including immune, protein breakdown, and CD38 targeting therapies.

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I have recovered from side effects of cancer treatment, except for hair loss.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Complete response rate

Duration of response

Overall response rate

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mezigdomide)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mezigdomide

2023

Completed Phase 1

~40

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,645 Total Patients Enrolled

37 Trials studying Multiple Myeloma

3,444 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,426 Total Patients Enrolled

581 Trials studying Multiple Myeloma

189,186 Patients Enrolled for Multiple Myeloma

Murali JanakiramPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

10 Total Patients Enrolled

1 Trials studying Multiple Myeloma

10 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered for this experimentation?

"Absolutely, as seen on clinicaltrials.gov this medical research project is still inviting volunteers to participate. The trial was first published on October 11th 2023 and has been recently updated on September 21st 2023. 15 subjects are being sought from a single location for this study."

Answered by AI

Has mezigdomide achieved regulatory acceptance from the FDA?

"Taking into account its current Phase 1 clinical trial status, our team at Power has assigned mezigdomide a safety score of 1; limited data is currently available regarding the efficacy and potential risks associated with this treatment."

Answered by AI

Are there any slots still available to participants in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is actively recruiting patients since its posting date of October 11th 2023 and most recent update nine days later on September 21st 2023. The research team expects 15 participants to join from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048250.