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

Conditions

• Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gamunex-C, 10% Injectable Solution — DRUG
  Sterile solution

Study Details

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).

Key Dates

Start date

Apr 23, 2026

Status verified

May 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

49 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: GAMUNEX®-C administered via IV Q4W

Primary Outcome Measure

serious bacterial infection (SBI) rate per-participant per year. [ Time Frame: 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 ]

Central Contacts

• Judith Wessels-Kranz
  +49 6103 801-6395,
  [email protected],
• Marina Acosta Enslen
  +1 (919) 813 9725
  [email protected]

Locations (5)

Find similar trials in St. Petersburg, FL