NCT06976476 Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
| NCT ID | NCT06976476 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2029-05-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-05-08 with a primary completion date of 2029-05-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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)
Contact & Investigator
Zainab Shahid, MBBS
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06976476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06976476 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06976476 currently recruiting?
Yes, NCT06976476 is actively recruiting participants. Contact the research team at shahidz@mskcc.org for enrollment information.
Where is the NCT06976476 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 4 additional locations.
Who is sponsoring the NCT06976476 clinical trial?
NCT06976476 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Zainab Shahid, MBBS at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 100 participants.