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RecruitingInterventionalPhase 2

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)

NCT ID: NCT06976476Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-03-11

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).

Arms & interventions

  • DrugIgPro20

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

Outcome measures

Primary

  • Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20

    To compare overall infection rates amongst (RR) multiple myeloma patients with hypogammaglobulinemia receiving subcutaneous immunoglobulin (IgPro20) to those in observational arm over a 6-month period.

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Diagnosis of RRMM receiving a commercially available bispecific antibody * Received at least 1 but no more than 4 cycles of BsAb * Males or females greater than or equal to 18 years old at the time of consent * ECOG ≤ 3 * Life expectancy \> 12 months Exclusion Criteria: * HSCT within 3 months before enrollment * Planned CAR-T therapy in the next 6 months * \>1 major (deep-seated) infection within the preceding 3 months * HIV infection, Active HCV, or Active HBV infection * Pregnancy * Neutrophils \< 500 x 10\^9 per mL, Platelets \< 30 x 10\^9 per mL * History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation * Known reaction/allergy to IgG products * Intracranial hemorrhage or embolic CVA in the last 6 months * Hyperproteinemia * Protein-losing enteropathy * Creatinine Cl \<30 ml/min * Documented progression on BsAb * Known history of Hyperprolinemia * On current or previous IVIG (in the last 3 months)

Study locations (8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 10065

Recruiting
Zainab Shahid, MBBS · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Zainab Shahnid, MBBS · Contact

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Zainab Shahid, MBBS · Contact

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)

Commack, New York, 11725

Recruiting
Zainab Shahid, MBBS · Contact

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Zainab Shahid, MBBS · Contact

Mount Sinai Hospital

New York, New York, 10029

Not Yet Recruiting
Cesar Rodriguez, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Zainab Shahid, MBBS · Contact

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

Recruiting
Zainab Shahid, MBBS · Contact