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.
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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

Judith Wessels-Kranz

+49 6103 801-6395,

judith.wesselskranz@external.grifols.com,

CONTACT

Marina Acosta Enslen

+1 (919) 813 9725

marina.acostaenslen@grifols.com

CONTACT