Using IgPro20 to prevent infections in patients with multiple myeloma and low immunoglobulin levels
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)
PHASE2 · Memorial Sloan Kettering Cancer Center · NCT06976476
This study is testing if IgPro20 can help prevent infections in people with multiple myeloma and low immune levels who are receiving certain treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | CAR-T, chemotherapy, radiation |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT06976476 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of IgPro20 in preventing infections in individuals diagnosed with multiple myeloma who also have hypogammaglobulinemia. Participants will be those receiving bispecific monoclonal antibodies and will have undergone a specific number of treatment cycles. The study aims to determine if IgPro20 can enhance the immune response and reduce infection rates in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed/refractory multiple myeloma receiving bispecific antibodies and exhibiting hypogammaglobulinemia.
Not a fit: Patients with recent major infections, certain viral infections, or those undergoing specific therapies like CAR-T may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce infection rates in patients with multiple myeloma and low immunoglobulin levels.
How similar studies have performed: Other studies have explored similar immunoglobulin therapies, showing promise in infection prevention, but this specific approach with IgPro20 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity) — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (RECRUITING)
- Mount Sinai Hospital — New York, New York, United States (NOT_YET_RECRUITING)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Zainab Shahid, MBBS — Memorial Sloan Kettering Cancer Center
- Study coordinator: Zainab Shahid, MBBS
- Email: shahidz@mskcc.org
- Phone: 212-639-6483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired, IgPro20, Memorial Sloan Kettering Cancer Center, 24-137