A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Recruiting
Phase 3
Interventional Study
Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 49 (estimated)
- Sponsor
- Grifols Biologicals, LLC · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Participants with documented and confirmed diagnosis of any of the diseases below:
* B-cell CLL according to iwCLL criteria and Rai staging of intermediate (1 and 2) or high (3 and 4); or
* MM according to the International Myeloma Working Group criteria (IMWG), R ISS stage II …
Contacts