Multiple MyelomaPhase 4NCT07154537
Pneumococcal Conjugated Vaccine 13 (PCV13) for Patients With Multiple Myeloma (MM)
A Phase 4 study testing 2-dose PCV13 and 1-dose PCV13 in people with Multiple Myeloma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Multiple myeloma patients often get serious infections that can be deadly. A British study looked at newly diagnosed patients and found that bacterial infections were the main cause of death in the first 60 days, mostly from pneumonia (66%) and blood poisoning (23%). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- 2-dose PCV13 and 1-dose PCV13
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2016to 31 Jul 2027
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma
- Stable clinical condition to have vaccination at outpatient clinic
Who cannot join
- Those who have received pneumococcal vaccine within the past five years
- Unable to communicate verbally with the subject
- Subject has an active infection
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Pneumococcal Conjugated Vaccine 13 (PCV13) in Patients With Multiple Myeloma
Multiple myeloma patients often get serious infections that can be deadly. A British study looked at newly diagnosed patients and found that bacterial infections were the main cause of death in the first 60 days, mostly from pneumonia (66%) and blood poisoning (23%). The most common bacteria causing these infections were pneumococcus, staph, and E. coli.
Medical experts recommend that multiple myeloma patients get pneumonia vaccines. However, some studies show these vaccines don't work well in these patients, raising questions about whether they're really helpful. It's also unclear if patients need one shot or multiple shots like other high-risk patients.
This study at National Taiwan University Hospital will randomly give multiple myeloma patients either one or two doses of the 13-valent pneumonia vaccine. Researchers will check if the vaccine is safe and if it helps the immune system fight infections, while trying to figure out what makes the vaccine work better in some patients than others.
Read the detailed description
Infection has always been a common and potentially life-threatening problem for multiple myeloma patients. A British study on newly diagnosed multiple myeloma patients investigated the causes of death within 60 days of enrollment and found that bacterial infection was the most common cause of death, followed by kidney failure, myocardial infarction, or stroke. Among patients who died from bacterial infections, 66% died from pneumonia, 23% from sepsis, and 11% from other infections. Among bacterial infection patients with culture results, Streptococcus pneumoniae was the most common pathogen, followed by Staphylococcus aureus and Escherichia coli.
The International Myeloma Working Group recommends that multiple myeloma patients receive pneumococcal vaccination. Some research findings have shown that pneumococcal vaccination in multiple myeloma patients is ineffective or very limited in effectiveness, questioning the recommendation for routine pneumococcal vaccination. Furthermore, it remains unknown whether multiple doses of vaccine are needed, as in hematopoietic stem cell transplant patients.
Therefore, for multiple myeloma patients at National Taiwan University Hospital, this study aims to randomly assign patients to receive either one or two doses of 13-valent pneumococcal conjugate vaccine, evaluate its safety and immune response generation, and identify factors related to vaccine efficacy.
- Conditions
- Multiple Myeloma
- Being tested
- 2-dose PCV13, 1-dose PCV13
- Keywords
- multiple myeloma, Immunogenicity, pneumococcal conjugated vaccine 13 (PCV13), safety
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-dose PCV13Biological
2 doses PCV13 with one month apart
1-dose PCV13Biological
1 dose PCV13
| Study group | Role | What they receive |
|---|---|---|
| 2-dose PCV13 | Experimental | 2 doses PCV13 with one month apart Receives: Biological: 2-dose PCV13 |
| 1-dose PCV13 | Active comparator | 1 dose PCV13 Receives: Biological: 1-dose PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity to serotype 6B, 14, 23F, 19F
Measured: before every dose of PCV13, and 4 weeks, every 12 weeks for one year, and every year for 5 years after the last dose of PCV13
Secondary outcomes (4)
Safety of PCV13
adverse effects within one week after each dose of PCV13
Measured: within one week after each dose of PCV13
invasive pneumococcal diseases
Measured: after the last dose of PCV13 for 5 years
Mortality
death and causes of death
Measured: after the last dose of PCV13 for 5 years
Pneumonia
Measured: after the last dose of PCV13 for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start23 Mar 2016
- Primary completion3 Apr 2024
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hsin-Yun Sun, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154537
- Sponsor's protocol ID
- 201511041MIND
- Other IDs
- MOHW109-TDU-B-211-114002, MOHW108-TDU-B-211-133002, MOHW106-CDC-C-11400104
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Pneumococcal Conjugated Vaccine 13 (PCV13) in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07154537
- Acronym / sponsor ID
- 201511041MIND
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Immunogenicity, pneumococcal conjugated vaccine 13 (PCV13), safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
Multiple myeloma patients often get serious infections that can be deadly. A British study looked at newly diagnosed patients and found that bacterial infections were the main cause of death in the first 60 days, mostly from pneumonia (66%) and blood poisoning (23%). The most common bacteria causing these infections were pneumococcus, staph, and E. coli.
Medical experts recommend that multiple myeloma patients get pneumonia vaccines. However, some studies show these vaccines don't work well in these patients, raising questions about whether they're really helpful. It's also unclear if patients need one shot or multiple shots like other high-risk patients.
This study at National Taiwan University Hospital will randomly give multiple myeloma patients either one or two doses of the 13-valent pneumonia vaccine. Researchers will check if the vaccine is safe and if it helps the immune system fight infections, while trying to figure out what makes the vaccine work better in some patients than others.
Detailed description
Infection has always been a common and potentially life-threatening problem for multiple myeloma patients. A British study on newly diagnosed multiple myeloma patients investigated the causes of death within 60 days of enrollment and found that bacterial infection was the most common cause of death, followed by kidney failure, myocardial infarction, or stroke. Among patients who died from bacterial infections, 66% died from pneumonia, 23% from sepsis, and 11% from other infections. Among bacterial infection patients with culture results, Streptococcus pneumoniae was the most common pathogen, followed by Staphylococcus aureus and Escherichia coli.
The International Myeloma Working Group recommends that multiple myeloma patients receive pneumococcal vaccination. Some research findings have shown that pneumococcal vaccination in multiple myeloma patients is ineffective or very limited in effectiveness, questioning the recommendation for routine pneumococcal vaccination. Furthermore, it remains unknown whether multiple doses of vaccine are needed, as in hematopoietic stem cell transplant patients.
Therefore, for multiple myeloma patients at National Taiwan University Hospital, this study aims to randomly assign patients to receive either one or two doses of 13-valent pneumococcal conjugate vaccine, evaluate its safety and immune response generation, and identify factors related to vaccine efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-dose PCV13 | Experimental | Biological: 2-dose PCV132 doses PCV13 with one month apart |
| 1-dose PCV13 | Active comparator | Biological: 1-dose PCV131 dose PCV13 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with multiple myeloma
- Stable clinical condition to have vaccination at outpatient clinic
Key exclusion criteria (4 listed)
- Those who have received pneumococcal vaccine within the past five years
- Unable to communicate verbally with the subject
- Subject has an active infection
- Pregnant women
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 |
|---|---|---|
| 2-dose PCV132 doses PCV13 with one month apart | Biological | 2-dose PCV13 |
| 1-dose PCV131 dose PCV13 | Biological | 1-dose PCV13 |
Primary outcome
Immunogenicity to serotype 6B, 14, 23F, 19F
Time frame: before every dose of PCV13, and 4 weeks, every 12 weeks for one year, and every year for 5 years after the last dose of PCV13
4 secondary outcomes
Safety of PCV13
Time frame: within one week after each dose of PCV13
invasive pneumococcal diseases
Time frame: after the last dose of PCV13 for 5 years
Mortality
Time frame: after the last dose of PCV13 for 5 years
Pneumonia
Time frame: after the last dose of PCV13 for 5 years
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 4 Sep 2025.
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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. This study is not recruiting at the moment.
Hsin-Yun Sun, M.D., Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2-dose PCV13 and 1-dose PCV13 in people with Multiple Myeloma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity to serotype 6B, 14, 23F, 19F (time frame: before every dose of PCV13, and 4 weeks, every 12 weeks for one year, and every year for 5 years after the last dose of PCV13). 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 4 Sep 2025.