ClinicalTrials.gg
RecruitingNCT06976476Updated Oct 5, 2026

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

A Phase 2 interventional study of IgPro20 in Multiple Myeloma, Hypogammaglobulinemia and Hypogammaglobulinemia, Acquired, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Updated Oct 5, 20261 site addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Myeloma
  • Hypogammaglobulinemia
  • Hypogammaglobulinemia, Acquired

Keywords

  • Multiple Myeloma
  • Hypogammaglobulinemia
  • IgPro20
  • Memorial Sloan Kettering Cancer Center
  • 24-137
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • ≤ 3
  • > 12 months

Exclusion criteria

Exclusion Criteria:

  • within 3 months before enrollment
  • Planned CAR-T therapy in the next 6 months
  • >1 major (deep-seated) infection within the preceding 3 months
  • infection, Active , or Active infection
  • Pregnancy
  • Neutrophils \< 500 x 10\^3 per mL, \< 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)
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Standard of Care

    Participants will only be observed

  • Experimental
    Standard of Care + IGRT prophylaxis with IgPro20

    Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care

    Drug: IgPro20

Interventions

  • Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump

    Also known as: HIZENTRA

06

What researchers measure

Primary outcomes

  1. Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20

    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.

    Time frame: 6 months

07

Study locations

8 of 9 sites recruiting
  • Emory University (Data Collection Only)
    Atlanta, Georgia 30322, United States
    Recruiting
    • Nooka Ajay, MD, MPH · Contact404-778-1900
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
    Basking Ridge, New Jersey 10065, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Zainab Shahnid, MBBS · Contact212-639-6483
  • Memorial Sloan Kettering Bergen (All Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
    Commack, New York 11725, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
  • Mount Sinai Hospital
    New York, New York 10029, United States
    Not yet recruiting
    • Cesar Rodriguez, MD · Contact212-241-7873
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
  • Memorial Sloan Kettering Nassau (All Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Zainab Shahid, MBBS · Contact212-639-6483
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • Emory University (Data Collection Only) · Atlanta, United States
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    1 site added
    Show site
    • Emory University (Data Collection Only) · Atlanta, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06976476
Responsible party
Sponsor
First posted
May 16, 2025
Start date
May 8, 2025
Primary completion
May 8, 2029 (estimated)
Completion
May 8, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

Zainab Shahid, MBBS
Contact
shahidz@mskcc.org
212-639-6483
Sergio Giralt, MD
Contact
giralts@mskcc.org
646-608-3731
Zainab Shahid, MBBS
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Hizentra

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