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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 2

Conditions

Hypogammaglobulinemia, Acquired

Multiple Myeloma

Hypogammaglobulinemia

Treatments

Drug: IgPro20

Study type

Interventional

Funder types

Other

Identifiers

NCT06976476

24-137

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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 10^9 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)