Status:
RECRUITING
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Multiple Myeloma
Hypogammaglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06976476
Start Date
May 8 2025
End Date
May 8 2029
Last Update
December 15 2025
Active Locations (8)
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1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 10065
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
Commack, New York, United States, 11725