Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
NCT ID: NCT06976476
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-05-08
2029-05-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Participants will only be observed
No interventions assigned to this group
Standard of Care + IGRT prophylaxis with IgPro20
Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care
IgPro20
Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Interventions
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IgPro20
Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Zainab Shahid, MBBS
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Mount Sinai Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Zainab Shahid, MBBS
Role: primary
Zainab Shahnid, MBBS
Role: primary
Zainab Shahid, MBBS
Role: primary
Zainab Shahid, MBBS
Role: primary
Zainab Shahid, MBBS
Role: primary
Cesar Rodriguez, MD
Role: primary
Zainab Shahid, MBBS
Role: primary
Zainab Shahid, MBBS
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-137
Identifier Type: -
Identifier Source: org_study_id