Clinical trial · Interventional
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
NCT03619252CI-TRIAL-00060613completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Pneumococcal Infection | — | UNRESOLVED | — |
| Pneumococcal Pneumonia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Antibacterial Prophylaxis | Drug | — | UNRESOLVED |
| Vaccination with pneumococcal conjugate vaccine (PCV13) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaccination group
- description
- Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and enrolled in vaccination by pneumococcal conjugate vaccine (PCV13): 3 doses with 1 month interval, and fourth dose planned to be administered 6 months later.
- interventionNames
- Biological: Vaccination with pneumococcal conjugate vaccine (PCV13)
- type
- ACTIVE_COMPARATOR
- label
- Standard prophylaxis
- description
- Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and receiving standard institutional antibacterial prophylaxis by Levofloxacin 500 mg daily during the median four cycles of treatment by novel agents
- interventionNames
- Drug: Standard Antibacterial Prophylaxis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDWallington-Beddoe CT, Pitson SM. Novel therapies for multiple myeloma. Aging (Albany NY). 2017 Aug 28;9(8):1857-1858. doi: 10.18632/aging.101284. No abstract available. PMID 28854147
- BACKGROUNDSatlin MJ, Vardhana S, Soave R, Shore TB, Mark TM, Jacobs SE, Walsh TJ, Gergis U. Impact of Prophylactic Levofloxacin on Rates of Bloodstream Infection and Fever in Neutropenic Patients with Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2015 Oct;21(10):1808-14. doi: 10.1016/j.bbmt.2015.06.017. Epub 2015 Jul 3. PMID 26150022
- BACKGROUNDJung SH, Kang SJ, Jang HC, Ahn JS, Yang DH, Lee SS, Kim YK, Kim HJ, Lee JJ. Effect of levofloxacin prophylaxis for prevention of severe infections in multiple myeloma patients receiving bortezomib-containing regimens. Int J Hematol. 2014 Nov;100(5):473-7. doi: 10.1007/s12185-014-1672-1. Epub 2014 Sep 12. PMID 25212681
- BACKGROUNDCordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged >/=2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13. PMID 25870329
- RESULTStoma I, Karpov I, Iskrov I, Lendina I, Uss A. Clinical efficacy of pneumococcal vaccination in multiple myeloma patients on novel agents: Results of a prospective clinical study. Vaccine. 2020 Jun 19;38(30):4713-4716. doi: 10.1016/j.vaccine.2020.05.024. Epub 2020 May 14. PMID 32418789
- DERIVEDZorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.