BridgeMD
A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® plus Standard Medical Treatment Compared to Placebo plus Standard Medical Treatment to Prevent Infections in Patients with Hypogammaglobulinemia and Recurrent or Severe Infections Associated with B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
EU CTIS ID: 2022-502193-16-00
What this study is testing
to evaluate whether biweekly administered XEMBIFY + Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per subject per year in B-cell chronic lymphocytic leukemia (B-cell CLL), multiple myeloma (MM), and non-Hodgkin lymphoma (NHL) subjects with hypogammaglobulinemia (HGG) in comparison to the Placebo + SMT group.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or Female subjects ≥18 years of age at Screening Visit
- Subjects 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), RISS 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.
- Subjects with HGG with IgG levels <5g/L. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein [M-spike] to reflect the true polyclonal IgG concentration.)
- Subjects with documented history of at least one severe infection (bacterial or viral) or recurrent bacterial/viral infections (i.e., ≥ 3 infections) within 12 months before the Screening Visit. Severe infections (bacterial or viral) ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades).
- Subjects have signed an informed consent form (ICF) prior to initiation of any study procedures.
You likely can't join if
- Subjects with documented history of hematopoietic stem cell transplant
- Subjects have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement)
- Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study. Note: *True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
- Subjects with severe known kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) as determined by the Principal Investigator
- Subjects that have liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory
- Subjects who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis
See the full eligibility criteria
Who can join
- Male or Female subjects ≥18 years of age at Screening Visit
- Subjects 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), RISS 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.
- Subjects with HGG with IgG levels <5g/L. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein [M-spike] to reflect the true polyclonal IgG concentration.)
- Subjects with documented history of at least one severe infection (bacterial or viral) or recurrent bacterial/viral infections (i.e., ≥ 3 infections) within 12 months before the Screening Visit. Severe infections (bacterial or viral) ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades).
- Subjects have signed an informed consent form (ICF) prior to initiation of any study procedures.
What rules you out
- Subjects with documented history of hematopoietic stem cell transplant
- Subjects have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement)
- Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study. Note: *True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
- Subjects with severe known kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) as determined by the Principal Investigator
- Subjects that have liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory
- Subjects who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis
- This criterion has been removed in protocol version 6.0
- Subjects who currently have a known hyperviscosity syndrome or hypercoagulable states
- Subjects who have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection
- Subjects with non-controlled arterial hypertension (systolic blood pressure [SBP] >140 mmHg and/or diastolic blood pressure [DBP] >90 mmHg), and a heart rate (HR) >100 bpm
- Subjects have known substance or prescription drug abuse within 12 months before the Screening Visit
- Subjects 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
- Subjects have participated in another clinical trial within 30 days prior to Screening Visit (observational studies without investigative treatments [non-interventional] are permitted)
- Subjects/caregivers are unwilling to comply with any aspect of the protocol for the duration of the study
- In the opinion of the investigator, subjects may have compliance problems with the protocol and the procedures of the protocol
- Subjects with active infections or receiving therapeutic or prophylactic antibiotic treatment at time of Screening Visit. Specific supportive anti-infective prophylactics defined in the CLL NCCN or iwCLL guidelines or recommended in the updated labelling of specific antileukemic medicines used during the participation in the trial is allowed
- Subjects with active second malignancies
- Subjects with known primary immunodeficiency (PI)
- Subject with a life expectancy less than 1.5 years
- Subjects with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk
- Subjects have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product
- Subjects have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator’s discretion
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.