Health Trials

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

ConditionsHypogammaglobulinemiaBacterial InfectionsB-cell Chronic Lymphocytic LeukemiaMultiple MyleomaNon-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrifols Therapeutics LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥18 years of age at screening visit

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

Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification.

Disqualifiers

Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.

Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.

Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and/or local/international guidelines for the CLL, and defined in local/international guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.

Participants with active second malignancies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xembify

    Drug

    SC infusion pump

  • Placebo

    Drug

    SC infusion pump

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: XEMBIFY + Standard Medical Treatment (SMT)Experimental treatment 1 intervention
Group B: Placebo + SMTPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annual Rate of Major Bacterial Infections per Year

Time frame
Up to Week 51

Secondary outcomes

1

Time to First Onset of Major Bacterial Infection

Time frame
Up to Week 51
2

Percentage of Participants who Experience Major Bacterial Infections

Time frame
Up to Week 51
3

Rate of all Bacterial Infections Determined by the Investigator

Time frame
Up to Week 51
4

Percentage of Participants who Experience Bacterial Infections

Time frame
Up to Week 51

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grifols Therapeutics LLC

Lead sponsor

Source ClinicalTrials.gov
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