A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.

Trial Details

NCT ID
NCT05645107
Phase
PHASE3
Sponsor
Grifols Therapeutics LLC
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Xembify
  • Placebo
Locations (sample)
  • Huntington Park, California, United States|33.98168,-118.22507
  • St. Petersburg, Florida, United States|27.77086,-82.67927
  • Bethesda, Maryland, United States|38.98067,-77.10026
  • Greenville, North Carolina, United States|35.61266,-77.36635
  • Canton, Ohio, United States|40.79895,-81.37845

Key Eligibility Criteria

  • Participants ≥18 years of age at screening visit
  • Participants with documented and confirmed diagnosis of any of the below diseases:
  • B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)
  • MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or

For full eligibility, visit ClinicalTrials.gov.

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