Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

Sponsor
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03619252
Collaborator
Belarusian State Medical University (Other)
40
1
2
30
1.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Vaccination with pneumococcal conjugate vaccine (PCV13)
  • Drug: Standard Antibacterial Prophylaxis
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Nov 30, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vaccination group

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.

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.

Active Comparator: Standard prophylaxis

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

Drug: Standard Antibacterial Prophylaxis
Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.

Outcome Measures

Primary Outcome Measures

  1. Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents. [One year]

Secondary Outcome Measures

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [One year]

    Data on Common Terminology Criteria for Adverse Events (CTCAE v4.0) will be collected via questionnaires. Measurement data will be aggregated in electronic platform to characterize the frequency, severity and interference of symptomatic treatment toxicities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus Minsk Belarus 220045

Sponsors and Collaborators

  • Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
  • Belarusian State Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ihar Iskrou, Head of Cell Transplant Division, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
ClinicalTrials.gov Identifier:
NCT03619252
Other Study ID Numbers:
  • HEM-3_2
First Posted:
Aug 7, 2018
Last Update Posted:
Sep 2, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2020