RecruitingPhase 2NCT06523621

Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel

Nivolumab As An Adjunctive Therapy In Relapsed Refractory Multiple Myeloma Patients With Sub-Optimal Response To Idecabtagene Vicleucel


Sponsor

Wake Forest University Health Sciences

Enrollment

50 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to evaluate if treatment with adjuvant nivolumab improves depth of response in patients with relapsed refractory multiple myeloma (RRMM) who achieve a less-than-ideal response to idecaptagene vicleucel.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called nivolumab (an immune checkpoint inhibitor) after a CAR-T cell therapy called idecabtagene vicleucel (ide-cel) can help multiple myeloma patients maintain their response to treatment for longer. Ide-cel is an advanced cell therapy that reprograms the patient's own immune cells to fight myeloma. **You may be eligible if...** - You are 18 or older - You have multiple myeloma and recently received ide-cel (CAR-T) treatment according to approved guidelines - Your myeloma responded to ide-cel (partial response or better) - You are enrolling between 3 and 6 weeks after your ide-cel infusion - Your overall health status is good (ECOG 0–1) - Your organ function (blood, liver, kidneys) meets the required levels **You may NOT be eligible if...** - You have Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis - You have an active serious infection (including uncontrolled HIV, active hepatitis B or C, or active TB) - You are pregnant or breastfeeding - You currently have cytokine release syndrome or neurotoxicity - You have had a stem cell transplant (allogeneic) or solid organ transplant - You have active autoimmune disease requiring treatment or a history of severe lung inflammation - You have a history of myocarditis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

2 cycles of nivolumab at a dose of 480 mg given over approximately 30-minutes intravenously on Day 1 of each treatment cycle


Locations(2)

Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06523621


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