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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518420-80-00 | EU Trial (CTIS) Number | EU CTIS Number |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
| Baxalta Innovations GmbH, now part of Takeda | UNKNOWN |
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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:
During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period of up to 8 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Infection Prophylaxis: IGI, 10% | Experimental | Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10%, intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months. |
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| Secondary Infection Prophylaxis: IGI, 10% | Active Comparator | Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10%, IV every 3 or 4 weeks only after experiencing at least one serious infection, as determined by the investigator, for the remainder of the 12 months observational period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGI, 10% | Biological | IGI, 10% IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time To the First Serious Infection | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least 1 Serious Infection | Up to 12 months | |
| Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections | Up to 12 months | |
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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 within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
The participant or the participant's legally acceptable representative 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infirmary Health - Diagnostic & Medical Clinic (DMC) | Recruiting | Mobile | Alabama | 36604 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Annualized Rate of Bacterial Infections |
| Up to 12 months |
| Annualized Rate of Serious Infections | Up to 12 months |
| Annualized Rate of Acute Serious Bacterial Infections (ASBIs) | Up to 12 months |
| Number of Participants With Any Infections | Up to 12 months |
| Duration of Infections | Up to 12 months |
| Time To Any First Infection | Up to 12 months |
| Annualized Rate of Any Infections | Up to 12 months |
| Number of Participants With Bacterial/Viral Infection/Fungal Infection | Number of participants with bacterial/viral infection, including covid/fungal infection diagnosed clinically and via microbiology (culture, polymerase chain reaction [PCR], other imaging will be reported. | Up to 12 months |
| Annualized Rate of Episodes of Fever due to Infections | Up to 12 months |
| Total Immunoglobulin G (IgG) Levels in Serum | 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364 |
| IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Levels in Serum | 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364 |
| Antigen-specific Antibody Levels in Serum | 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364 |
| Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs) | Up to 12 months |
| Number of Participants With TEAEs Related to IGI, 10% | Up to 12 months |
| Number of Participants With TEAEs Temporally Associated to the IGI, 10% Within 72 hours of Administration | Within 72 hours of IGI, 10% administration (up to 12 months) |
| Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10% | Up to 12 months |
| Number of Participants With at Least 1 Hospitalization due to Infection | Up to 12 months |
| Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection | Up to 12 months |
| Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection | Up to 12 months |
| Duration of Hospitalizations, Including ICU and Non-ICU due to Infection | Up to 12 months |
| Number of Days of Hospitalization per Participant-year, Including ICU and Non-ICU due to Infection or Other Reasons | Up to 12 months |
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| Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
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| A O Krankenhaus der Elisabethinen | Recruiting | Linz | 4020 | Austria |
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| Universitaetsklinikum St. Poelten | Recruiting | Sankt Pölten | 3100 | Austria |
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| Krankenhaus der Barmherzigen Schwestern Wien | Recruiting | Vienna | 1060 | Austria |
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| Odense Universitetshospital | Recruiting | Odense | 5000 | Denmark |
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| Alexandra General Hospital of Athens | Recruiting | Athens | 105 57 | Greece |
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| Somogy Megyei Kaposi Mor Oktato Korhaz | Recruiting | Kaposvár | 7400 | Hungary |
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| Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica | Recruiting | Torrette | 60126 | Italy |
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| Amsterdam University Medical Center (Amsterdam UMC) | Recruiting | Amsterdam | 1019PE | Netherlands |
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| St. Antonius Ziekenhuis | Recruiting | Nieuwegein | 3435 | Netherlands |
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| Aidport sp. z o.o. | Recruiting | Skorzewo | 60-185 | Poland |
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| Hospital Costa Del Sol | Recruiting | Marbella | 29603 | Spain |
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| Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD) | Recruiting | Palma de Mallorca | 7120 | Spain |
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| County Hospital (Stafford Hospital) | Recruiting | Stafford | ST16 3SA | United Kingdom |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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