Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT06980480 · Takeda

A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma

What this study is about

Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy.

View original scientific description

Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy. Participants will be randomly assigned to one of two groups: 1.

Interventions

BIOLOGICAL

IGI, 10%

IGI, 10% IV infusion.

Primary outcome measures

Time To the First Serious Infection

Time frame: Up to 12 months

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.
  • Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
  • The participant has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form \[ICF\]) and any required privacy authorization before the initiation of any study procedures.
  • The participant is at least 18 years of age at the time of signing the ICF.
  • If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug:
  • To use a highly effective contraceptive method.
  • To avoid donating ova.

Exclusion criteria

  • The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab.
  • The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
  • The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standard practice.
  • The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
  • The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
  • The participant has received live viral vaccines within 30 days before screening.
  • The participant has an Eastern Cooperative Oncology Group performance status score of \>2.
  • The participant has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.
  • The participant has received other B Cell Maturation Antigen (BCMA)\*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or BCMA-targeted antibody drug conjugate (ADC) therapy within 1 year prior to screening.
  • The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
  • The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome.
  • The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical procedures to be conducted under local anesthesia may participate).
  • The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years.
  • The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and/or immune serum globulin infusions.
  • The participant has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.
  • The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than (\<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), as defined by kidney disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.
  • The participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
  • The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.
  • The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase \>3.0 times the upper limit of normal (ULN) at screening (may be repeated once to determine if it is persistent).
  • The participant has an immunoglobulin A (IgA) deficiency (\<0.07 grams per liter \[g/L\]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
  • Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure/package insert/Summary of Product Characteristics.
  • Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
  • The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
  • The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the participant at undue medical risk.
  • The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
  • The participant is not willing and able to comply with the protocol requirements.
  • The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study.
  • The participant is a family member or employee of the investigator or the investigator's site staff.
  • The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.

Where

  • Mobile, Alabama
  • Orange, California
  • Westwood, Kansas
  • Baltimore, Maryland
  • Detroit, Michigan
  • St Louis, Missouri
  • Albany, New York

Collaborators

Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda

Related conditions & keywords

Multiple MyelomaSecondary ImmunodeficiencyDrug Therapy

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations

📊
1 of 183 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Mobile

Alabama

Location available
RECRUITING

Orange

California

Location available
RECRUITING

Westwood

Kansas

Location available
RECRUITING

Baltimore

Maryland

Location available
RECRUITING

Detroit

Michigan

Location available
RECRUITING

St Louis

Missouri

Location available
RECRUITING

Albany

New York

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Multiple Myeloma Trials by City

Browse all multiple myeloma clinical trials in these cities — not just this study.

Browse More Trials by Condition

Looking for Multiple Myeloma Treatment in Mobile?

Join others in Alabama exploring innovative treatment options through clinical research

Multiple Myeloma Treatment Options in Mobile, Alabama

If you're searching for Multiple Myeloma treatment in Mobile, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Mobile, Orange, Westwood and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Multiple Myeloma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 183 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Multiple Myeloma?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Multiple Myeloma

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Multiple Myeloma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06980480. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.