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Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

NCT03619252 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-08-31

No results posted yet for this study

Summary

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals. Novel agents (proteasome inhibitors, immunomodulatory agents) have substantially improved the overall response rates, progression-free survival and overall survival in patients with multiple myeloma. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections, while clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before. The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

Conditions

Interventions

BIOLOGICAL

Vaccination with pneumococcal conjugate vaccine (PCV13)

Vaccination with pneumococcal conjugate vaccine - PCV13 (Prevnar 13/Prevenar 13, Pfizer Inc) containing saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria cross-reactive material. Vaccination regimen: 3 doses monthly, with a booster dose 6 months later.

DRUG

Standard Antibacterial Prophylaxis

Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.

Sponsors & Collaborators

  • Belarusian State Medical University

    collaborator OTHER

  • Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

    lead OTHER_GOV

Principal Investigators

  • Anatoly Uss, MD/PhD · Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-01-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • Belarus

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619252 on ClinicalTrials.gov