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

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).

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Key information

Conditions

Multiple Myeloma Agammaglobulinemia Blood Protein Disorders Cardiovascular Diseases Common Variable Immunodeficiency Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypogammaglobulinemia Hypogammaglobulinemia, Acquired Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IgPro20

Drug

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

Other names: HIZENTRA

Primary outcomes

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

Time frame: 6 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio Giralt, MD

CONTACT

[email protected]

646-608-3731

Zainab Shahid, MBBS

CONTACT

[email protected]

212-639-6483

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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)

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: May 16, 2025
Registry last updated: Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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