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Trial record 2 of 2 for:    "Streptococcus Pneumonia" | "Levofloxacin"

Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

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ClinicalTrials.gov Identifier: NCT03619252
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2018
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Ihar Iskrou, Minsk State Clinical Hospital No 9

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
Multiple Myeloma Pneumococcal Infection Febrile Neutropenia Pneumococcal Pneumonia 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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.




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

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619252


Locations
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Belarus
Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus
Minsk, Belarus, 220045
Sponsors and Collaborators
Minsk State Clinical Hospital No 9
Belarusian State Medical University
Investigators
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Study Chair: Anatoly Uss, MD/PhD Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus

Publications:
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Responsible Party: Ihar Iskrou, Head of Cell Transplant Division, Minsk State Clinical Hospital No 9
ClinicalTrials.gov Identifier: NCT03619252     History of Changes
Other Study ID Numbers: HEM-3_2
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pneumococcal Infections
Pneumonia, Pneumococcal
Multiple Myeloma
Neoplasms, Plasma Cell
Pneumonia
Neutropenia
Febrile Neutropenia
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Agranulocytosis
Leukopenia
Leukocyte Disorders
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Bacterial Agents