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)
1 other identifier
interventional
100
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started May 2025
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2029
March 11, 2026
March 1, 2026
4 years
May 8, 2025
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
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.
6 months
Study Arms (2)
Standard of Care
NO INTERVENTIONParticipants will only be observed
Standard of Care + IGRT prophylaxis with IgPro20
EXPERIMENTALParticipants will receive IGRT prophylaxis with IgPro20 in addition to standard of care
Interventions
Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 10065, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zainab Shahid, MBBS
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 16, 2025
Study Start
May 8, 2025
Primary Completion (Estimated)
May 8, 2029
Study Completion (Estimated)
May 8, 2029
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.