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

RECRUITINGPhase 2Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 2
SponsorMemorial Sloan Kettering Cancer Center
Started2025-05-08
Est. completion2029-05-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites

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

Age: 18 Years+Healthy volunteers accepted
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)

Conditions4

CancerHypogammaglobulinemiaHypogammaglobulinemia, AcquiredMultiple Myeloma

Locations8 sites

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 10065
Zainab Shahid, MBBS212-639-6483
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Zainab Shahnid, MBBS212-639-6483
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Zainab Shahid, MBBS212-639-6483
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
Commack, New York, 11725
Zainab Shahid, MBBS212-639-6483
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Zainab Shahid, MBBS212-639-6483

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