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NCT Number: NCT07154537

Pneumococcal Conjugated Vaccine 13 (PCV13) for Patients With Multiple Myeloma (MM)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with multiple myeloma
  • Stable clinical condition to have vaccination at outpatient clinic

Exclusion criteria

  • 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

Treatment and study plan

2-dose PCV13

Biological

2 doses PCV13 with one month apart

1-dose PCV13

Biological

1 dose PCV13

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety of PCV13

    Time frame: within one week after each dose of PCV13

    adverse effects within one week after each dose of PCV13

  2. invasive pneumococcal diseases

    Time frame: after the last dose of PCV13 for 5 years

  3. Mortality

    Time frame: after the last dose of PCV13 for 5 years

    death and causes of death

  4. Pneumonia

    Time frame: after the last dose of PCV13 for 5 years

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Ministry of Health and Welfare, Taiwan

Registry information

Official study title

Immunogenicity and Safety of Pneumococcal Conjugated Vaccine 13 (PCV13) in Patients With Multiple Myeloma

Important dates

Study start
2016
Primary completion
2024
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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