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The main goal of this study is to show that people with certain immune problems (from Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma) get fewer serious infections when they receive Gamunex C through an IV once every 4 weeks, along with their usual medical care, for one year.
All participants will receive Gamunex-C 500 mg/kg once every 4 weeks (total 13 doses) starting Day 1 (Week 1) through Week 48 (end of Treatment Phase).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAMUNEX®-C administered via IV Q4W | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamunex-C, 10% Injectable Solution | Drug | Sterile solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| serious bacterial infection (SBI) rate per-participant per year. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first onset of SBI | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first | |
| Time to first onset of severe bacterial infection | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
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Inclusion Criteria:
Participants with documented and confirmed diagnosis of any of the diseases below:
Participants with HGG with IgG levels <5g/L at screening.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Wessels-Kranz | Contact | +49 6103 801-6395, | judith.wesselskranz@external.grifols.com, | |
| Marina Acosta Enslen | Contact | +1 (919) 813 9725 | marina.acostaenslen@grifols.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 102 | Not yet recruiting | St. Petersburg | Florida | 33709 | United States |
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| Proportion of participants who experience at least one severe bacterial infection. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The rate of severe bacterial infections per participant per year. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The rate of all bacterial infections per participant per year. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Time to first onset of non-severe bacterial infection. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The proportion of participants who experience at least one bacterial infection. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Time to first onset of any kind of infection (bacterial/viral/fungal). | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The proportion of participants who experience a validated infection | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The rate of validated (as defined above) infections per participant per year | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral). | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The number of days on prophylactic antibiotics per participant per year | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral). | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The number of days on therapeutic antibiotics per participant per year | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Number of hospitalizations due to any infections | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Total duration of hospitalizations due to any infections | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| The rate of hospitalizations per participant per year due to any infections. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Rate of infections requiring IV administration of an antibiotic or antiviral/anti infective per-participant per year. | During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first. |
| Study Site 101 | Recruiting | Fort Wayne | Indiana | 46894 | United States |
|
| Study Site 105 | Not yet recruiting | Westbrook | Maine | 04092 | United States |
|
| Study Site 104 | Not yet recruiting | Columbus | Ohio | 43210 | United States |
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| Study Site 103 | Not yet recruiting | Tacoma | Washington | 98405 | United States |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C558471 | Hizentra |
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