Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin LymphomaPhase 3SIGMANCT07582432
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
A Phase 3 study testing Gamunex-C, 10% Injectable Solution in people with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma, run by Grifols Biologicals, LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
- What is being tested?
- Gamunex-C, 10% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 May 2026to 31 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Study Site 104
Columbus, Ohio, 43210
GC2502@grifols.com
- Recruiting
Study Site 101
Fort Wayne, Indiana, 46894
GC2502@grifols.com
- Not yet recruiting
Study Site 102
St. Petersburg, Florida, 33709
GC2502@grifols.com
- Not yet recruiting
Study Site 103
Tacoma, Washington, 98405
GC2502@grifols.com
- Not yet recruiting
Study Site 105
Westbrook, Maine, 04092
GC2502@grifols.com
About this study
Official title: 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
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).
- Being tested
- Gamunex-C, 10% Injectable Solution
- Keywords
- Phase 3, Clinical trial, Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamunex-C, 10% Injectable SolutionDrug
Sterile solution
| Study group | Role | What they receive |
|---|---|---|
| GAMUNEX®-C administered via IV Q4W | Experimental | Not described Receives: Drug: Gamunex-C, 10% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious bacterial infection (SBI) rate per-participant per year.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Secondary outcomes (19)
Time to first onset of SBI
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Time to first onset of severe bacterial infection
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Proportion of participants who experience at least one severe bacterial infection.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of severe bacterial infections per participant per year.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of all bacterial infections per participant per year.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of non-severe bacterial infection.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience at least one bacterial infection.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of any kind of infection (bacterial/viral/fungal).
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience a validated infection
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of validated (as defined above) infections per participant per year
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral).
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on prophylactic antibiotics per participant per year
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral).
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on therapeutic antibiotics per participant per year
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of hospitalizations due to any infections
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Total duration of hospitalizations due to any infections
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of hospitalizations per participant per year due to any infections.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Rate of infections requiring IV administration of an antibiotic or antiviral/anti infective per-participant per year.
Measured: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start11 May 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grifols Biologicals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582432
- Sponsor's protocol ID
- GC2502
- Acronym
- SIGMA
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07582432
- Acronym / sponsor ID
- SIGMA / GC2502
- Keywords
- Phase 3, Clinical trial, Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Grifols Biologicals, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAMUNEX®-C administered via IV Q4W | Experimental | Drug: Gamunex-C, 10% Injectable Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamunex-C, 10% Injectable SolutionSterile solution | Drug | GAMUNEX®-C administered via IV Q4W |
Primary outcome
serious bacterial infection (SBI) rate per-participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
19 secondary outcomes
Time to first onset of SBI
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Time to first onset of severe bacterial infection
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Proportion of participants who experience at least one severe bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of severe bacterial infections per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of all bacterial infections per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of non-severe bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience at least one bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of any kind of infection (bacterial/viral/fungal).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience a validated infection
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of validated (as defined above) infections per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on prophylactic antibiotics per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on therapeutic antibiotics per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of hospitalizations due to any infections
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Total duration of hospitalizations due to any infections
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of hospitalizations per participant per year due to any infections.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Rate of infections requiring IV administration of an antibiotic or antiviral/anti infective per-participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gamunex-C, 10% Injectable Solution in people with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma, run by Grifols Biologicals, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Wessels-Kranz (+49 6103 801-6395,, judith.wesselskranz@external.grifols.com,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious bacterial infection (SBI) rate per-participant per year. (time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.