A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Gamunex-C lowers the number of serious infections in people with low antibody levels caused by certain blood cancers. Antibodies help the body fight infections. Everyone gets Gamunex-C through an IV (a tube into a vein) every 4 weeks for 13 doses, along with their usual care, over about one year.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have one of these confirmed blood cancers: B-cell chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or B-cell non-Hodgkin lymphoma (NHL).
- For CLL: Rai stage 1, 2, 3, or 4. For MM: R-ISS stage II or III.
- For NHL: stage III or higher, including cancer that has returned or keeps growing despite treatment.
- Have low antibody levels, with IgG below 5 g/L at screening.
Who can't join
- Had a stem cell transplant from a donor in the past 6 months, or received antibody replacement treatment during that time.
- Have an active infection, another active cancer, signs of hepatitis B or C, or a known immune problem you were born with.
- Had a serious reaction to antibody treatment or a severe allergic reaction to blood products, or have a diagnosis called selective IgA deficiency.
- Are pregnant, breastfeeding, or able to become pregnant but unwilling to use highly effective birth control throughout the study.
- Have severe kidney disease, certain liver blood tests over 3 times normal, blood pressure over 160/100, or a heart rate over 100 beats per minute.
- Have overly thick blood or blood that clots too easily, or had certain blood clots or blocked blood vessels once in the past year or twice in your lifetime.
- Are expected to live less than 1.5 years, have another illness that makes the study unsafe or hard to finish, or had substance or prescription drug abuse in the past year.
- Cannot or will not follow study rules, or joined another trial in the past 30 days. Studies that only observe people and treatment studies for CLL, MM, or NHL are allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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. Exclusion Criteria: * Participants with documented history of allogeneic hematopoietic stem cell transplant within 6 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 any active infections at the time of Screening Visit. Participants with active secondary malignancies. * Participants with known PID. * Participants with a life expectancy less than 1.5 years. * Participants 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 participant at undue medical risk. * Participants who have had known serious treatment related adverse events to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product. * Participants who 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 PI 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 participant. (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.) * Participants with severe known kidney disease (as defined by estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration \[eGFR CKD-EPI\] \<30 mL/min/1.73 m2) as determined by the Principal Investigator. * Participants that have liver enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], or lactate dehydrogenase \[LDH\]) greater than 3 times the upper limit of normal at the Screening Visit as defined by the testing laboratory. * Participants who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of thromboembolic events \[e.g., DVT, PE, ischemic stroke (transient ischemic attack, and any ischemic cerebrovascular accident), myocardial infarction (including unstable angina and ischemic heart disease diagnosed in the last 6 months), retinal artery occlusion, mesenteric ischemia, and peripheral arterial disease (Fontaine III and IV)\]\*.(Fontaine I: asymptomatic. IIa: mild claudication. IIb: moderate to severe claudication. III: ischemia with rest pain. IV: ulceration or gangrene). * Participants who currently have a known hyperviscosity syndrome or hypercoagulable states. * Participants who have clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection. * Participants with non-controlled arterial hypertension (i.e., SBP \> 160 mmHg and/or DBP \> 100 mmHg), and/or HR \>100 bpm. * Participants have known substance or prescription drug abuse within 12 months before the Screening Visit. * Participants have participated in another clinical trial within 30 days prior to Screening Visit (NOTE: observational studies without investigative treatments \[non-interventional\] and interventional studies to treat CLL, MM, or NHL are permitted). * Participants / caregivers are unwilling to comply with any aspect of the protocol for the duration of the study. * In the opinion of the investigator, participants may have compliance problems with the protocol and the procedures of the protocol.
Study sites (5)
FL
- Study Site 102 · St. Petersburg, FL 33709 · Study contact · GC2502@grifols.comMore trials in St. Petersburg
IN
- Study Site 101 · Fort Wayne, IN 46894 · Study contact · GC2502@grifols.comMore trials in Fort Wayne
ME
- Study Site 105 · Westbrook, ME 04092 · Study contact · GC2502@grifols.comMore trials in Westbrook
OH
- Study Site 104 · Columbus, OH 43210 · Study contact · GC2502@grifols.comMore trials in Columbus
WA
- Study Site 103 · Tacoma, WA 98405 · Study contact · GC2502@grifols.comMore trials in Tacoma