Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

• Status: Enrolling by invitation
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology; Minsk State Clinical Hospital No 9
• Collaborator: Belarusian State Medical University
• Treatments: Anti-Bacterial Agents; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

Criteria

Inclusion Criteria:

• Patients with proven diagnosis of multiple myeloma

• Patients must be enrolled in treatment with novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab)

• Patients must have Creatinine Clearance above 30 mL/min on the Day 1 of trial

• Patients must have given informed consent to participate in trial.

Exclusion Criteria:

• Contraindication to the use of one of the study drug/vaccines (including known hypersensitivity)

• Creatinine Clearance below 30 mL/min on the Day 1 of trial

• Psychiatric disorder or unable to understand or to follow the protocol directions

• Active bacterial, viral, fungal or protozoal infection on the Day 1 of trial