RecruitingPhase 2NCT06976476

Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Prospective Randomized Phase II Study Evaluating Efficacy and Safety of IgPro20 as Infection Prophylaxis in Patients With Multiple Myeloma and Hypogammaglobulinemia Receiving Therapy With a Bispecific Monoclonal Antibody (BsAbs)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

100 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called IgPro20 (a type of antibody infusion given under the skin) can help prevent infections in people with multiple myeloma who have low antibody levels and are being treated with a newer type of drug called a bispecific antibody. **You may be eligible if...** - You have relapsed or refractory multiple myeloma (cancer that has come back or stopped responding to treatment) - You are currently receiving a commercially available bispecific antibody and have completed 1 to 4 treatment cycles - You are 18 or older - You are in reasonably good health with a life expectancy greater than 12 months **You may NOT be eligible if...** - You had a stem cell transplant in the last 3 months - You are planning CAR-T therapy in the next 6 months - You have had more than one serious deep-seated infection in the past 3 months - You have HIV, active hepatitis B or C - You are pregnant - You have very low white blood cell or platelet counts - You have had a stroke or brain bleed in the last 6 months - You have severe kidney disease (creatinine clearance below 30) - You are currently on or recently used IV immunoglobulin (IVIG) - You have a known allergy to IgG products 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

DRUGIgPro20

Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump


Locations(8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06976476


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