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

NCT07154537 | Active Not Recruiting Phase 4

• 4 other identifiers: 201511041MINDMOHW109-TDU-B-211-114002MOHW108-TDU-B-211-133002MOHW106-CDC-C-11400104
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; Immunogenicity; pneumococcal conjugated vaccine 13 (PCV13); safety

Outcome Measures

Primary Outcomes (1)

• Immunogenicity to serotype 6B, 14, 23F, 19F

  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

  within one week after each dose of PCV13

• invasive pneumococcal diseases

  after the last dose of PCV13 for 5 years

• Mortality

  after the last dose of PCV13 for 5 years

• Pneumonia

  after the last dose of PCV13 for 5 years

Study Arms (2)

2-dose PCV13

EXPERIMENTAL

2 doses PCV13 with one month apart

Biological: 2-dose PCV13

1-dose PCV13

ACTIVE COMPARATOR

1 dose PCV13

Biological: 1-dose PCV13

Interventions

2-dose PCV13 BIOLOGICAL

2 doses PCV13 with one month apart

2-dose PCV13

1-dose PCV13 BIOLOGICAL

1 dose PCV13

1-dose PCV13

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100226, Taiwan

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hsin-Yun Sun, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: March 23, 2016
• Primary Completion: April 3, 2024
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

TW (1)