Clinical trial NCT06976476: Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Hypogammaglobulinemia
Hypogammaglobulinemia, Acquired
Keywords: Multiple Myeloma
Hypogammaglobulinemia
IgPro20
Memorial Sloan Kettering Cancer Center
24-137
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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
* 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
* 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)

Primary outcomes:
measure: Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Zainab Shahid, MBBS
role: PRINCIPAL_INVESTIGATOR
References: