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) IGPRO20

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Phase 2

Enrollment: 100 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting
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