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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06976476

Enrollment

100

Registered

2025-05-16

Start date

2025-05-08

Completion date

2029-05-08

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired, Multiple Myeloma

Keywords

Multiple Myeloma, Hypogammaglobulinemia, IgPro20, Memorial Sloan Kettering Cancer Center, 24-137

Brief 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).

Interventions

DRUGIgPro20

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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\^3 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)

Design outcomes

Primary

Measure	Time frame	Description
Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20	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.

Countries

United States

Contacts

CONTACTZainab Shahid, MBBS

shahidz@mskcc.org212-639-6483

CONTACTSergio Giralt, MD

giralts@mskcc.org646-608-3731

PRINCIPAL_INVESTIGATORZainab Shahid, MBBS

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026