A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

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).

Trial Details

NCT ID

NCT07582432

Phase

PHASE3

Sponsor

Grifols Biologicals, LLC

Status

RECRUITING

Cancer Type

Multiple Myeloma

Interventions

Gamunex-C, 10% Injectable Solution

Locations (sample)

St. Petersburg, Florida, United States|27.77086,-82.67927
Fort Wayne, Indiana, United States|41.1306,-85.12886
Westbrook, Maine, United States|43.67703,-70.37116
Columbus, Ohio, United States|39.96118,-82.99879
Tacoma, Washington, United States|47.25288,-122.44429

Key Eligibility 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 or, III; or
Histologically confirmed diagnosis of B-cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lug…

For full eligibility, visit ClinicalTrials.gov.

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