Clinical trial · Interventional
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)
NCT06976476CI-TRIAL-00124952recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogammaglobulinemia | — | UNRESOLVED | — |
| Hypogammaglobulinemia, Acquired | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IgPro20 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Participants will only be observed
- type
- EXPERIMENTAL
- label
- Standard of Care + IGRT prophylaxis with IgPro20
- description
- Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care
- interventionNames
- Drug: IgPro20
Primary outcomes (1)
- measure
- Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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\^3 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)
References
Publications (0)
Data not yet available
No reference posted for this study.