Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Description

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

Multiple Myeloma, Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired

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Study Overview

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Study Details

Study overview

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).

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 of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States, 10065

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States, 10604

New York

Mount Sinai Hospital, New York, New York, United States, 10029

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Zainab Shahid, MBBS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2029-05-08