Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
Condition: Multiple Myeloma; Pneumococcal Infection; Febrile Neutropenia; Pneumococcal Pneumonia
MeSH terms: Pneumococcal Infections; Pneumonia, Pneumococcal; Multiple Myeloma; Neoplasms, Plasma Cell; Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older
      individuals with a median age at diagnosis of 69 years and a median overall survival of 6-7
      years [Kumar S.K., et al. Leukemia, 2014; Rollig C., et al. Lancet., 2015]. Over the past
      years novel agents have been introduced into clinical practice, showing improved overall
      response rates, progression-free survival and overall survival in patients with multiple
      myeloma. The main classes of novel agents include proteasome inhibitors, immunomodulatory
      agents and monoclonal antibodies. These agents are typically used in doublet or triplet
      regimens that include a chemotherapeutic drug and/or corticosteroid.

      Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality.
      Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus
      pneumoniae infections due to chemotherapy-associated immunosuppression. Vaccination is an
      important preventive strategy against infections caused by S. pneumoniae. In the past, the
      23-valent pneumococcal polysaccharide vaccine was recommended. However, polysaccharide
      vaccines have limited efficacy in cancer and hematology patients, because of the decreased T-
      and B-cell responses. Clinical efficacy and safety of conjugate pneumococcal vaccines in
      multiple myeloma patients receiving novel agents have not been studied before.

      In this study the investigators wish to study the effect of vaccination with 13-valent
      pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents
      (proteasome inhibitors and immunomodulatory drugs). 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.
    

Intervention name(s): Vaccination with pneumococcal conjugate vaccine (PCV13); Standard Antibacterial Prophylaxis
Intervention type(s): Biological; Drug
Intervention description(s): 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.; Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.
Intervention MeSH terms: Anti-Bacterial Agents; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention