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An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C Plus Standard Medical Treatment to Prevent Infections in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 Lugano Classification.

⁃ Participants with HGG with IgG levels \<5g/L at screening.

Locations
United States
Florida
Study Site 102
NOT_YET_RECRUITING
St. Petersburg
Indiana
Study Site 101
RECRUITING
Fort Wayne
Maine
Study Site 105
NOT_YET_RECRUITING
Westbrook
Ohio
Study Site 104
NOT_YET_RECRUITING
Columbus
Washington
Study Site 103
NOT_YET_RECRUITING
Tacoma
Contact Information
Primary
Judith Wessels-Kranz
judith.wesselskranz@external.grifols.com,
+49 6103 801-6395,
Backup
Marina Acosta Enslen
marina.acostaenslen@grifols.com
+1 (919) 813 9725
Time Frame
Start Date: 2026-04-23
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 49
Treatments
Experimental: GAMUNEX®-C administered via IV Q4W
Sponsors
Leads: Grifols Biologicals, LLC

This content was sourced from clinicaltrials.gov

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