RECRUITING

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

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Conditions

Multiple MyelomaHypogammaglobulinemiaHypogammaglobulinemia, AcquiredIgPro20Memorial Sloan Kettering Cancer Center24-137

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2025-05-08
Study Completion:2029-05-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of RRMM receiving a commercially available bispecific antibody
  2. * Received at least 1 but no more than 4 cycles of BsAb
  3. * Received 2 or more lines of therapy for MM IgG ≤ 4 g/L excluding paraprotein. For IgG Kappa MM, hypogammaglobulinemia will be determined by subtracting the M spike from IgG
  4. * Males or females greater than or equal to 18 years old at the time of consent
  5. * ECOG ≤ 3
  6. * Life expectancy \> 12 months
  1. * HSCT within 3 months before enrollment
  2. * Planned CAR-T therapy in the next 6 months
  3. * \>1 major (deep-seated) infection within the preceding 3 months
  4. * HIV infection, Active HCV, or Active HBV infection
  5. * Pregnancy
  6. * Neutrophils \< 500 x 10\^9 per mL, Platelets \< 30 x 10\^9 per mL
  7. * History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation
  8. * Known reaction/allergy to IgG products
  9. * Intracranial hemorrhage or embolic CVA in the last 6 months
  10. * Hyperproteinemia
  11. * Protein-losing enteropathy
  12. * Creatinine Cl \<30 ml/min
  13. * Documented progression on BsAb
  14. * Known history of Hyperprolinemia
  15. * On current or previous IVIG (in the last 3 months)

Contacts and Locations

Study Contact

Zainab Shahid, MBBS
CONTACT
212-639-6483
shahidz@mskcc.org
Sergio Giralt, MD
CONTACT
646-608-3731
giralts@mskcc.org

Principal Investigator

Zainab Shahid, MBBS
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Zainab Shahid, MBBS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08
Study Completion Date2029-05-08

Study Record Updates

Study Start Date2025-05-08
Study Completion Date2029-05-08

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma
  • Hypogammaglobulinemia
  • IgPro20
  • Memorial Sloan Kettering Cancer Center
  • 24-137

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Hypogammaglobulinemia
  • Hypogammaglobulinemia, Acquired