Multiple MyelomaPhase 4NCT03619252
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
A Phase 4 study testing Vaccination with pneumococcal conjugate vaccine (PCV13) and Standard Antibacterial Prophylaxis in people with Multiple Myeloma and Pneumococcal Infection, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma, Pneumococcal Infection, Febrile Neutropenia
- What is being tested?
- Vaccination with pneumococcal conjugate vaccine (PCV13) and Standard Antibacterial Prophylaxis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2018to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus
Minsk, 220045
About this study
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.
Read the 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.
- Being tested
- Vaccination with pneumococcal conjugate vaccine (PCV13), Standard Antibacterial Prophylaxis
- Medical subject headings
- Multiple Myeloma, Pneumococcal Infections, Febrile Neutropenia, Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with pneumococcal conjugate vaccine (PCV13)Biological
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.
Standard Antibacterial ProphylaxisDrug
Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination group | Experimental | 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. Receives: Biological: Vaccination with pneumococcal conjugate vaccine (PCV13) |
| Standard prophylaxis | Active comparator | 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 Receives: Drug: Standard Antibacterial Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents.
Measured: One year
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jul 2018
- Primary completion30 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Principal investigator, Ihar Iskrou, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Investigators
- Anatoly Uss, MD/PhD, Study chair, Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619252
- Sponsor's protocol ID
- HEM-3_2
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallington-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.
PubMed 28854147Satlin 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.
PubMed 26150022Jung 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.
PubMed 25212681Cordonnier 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.
PubMed 25870329Stoma 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.
PubMed 32418789Zorger 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.
PubMed 40396505
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
- ClinicalTrials.gov ID
- NCT03619252
- Acronym / sponsor ID
- HEM-3_2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and HematologyOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination group | Experimental | Biological: Vaccination with pneumococcal conjugate vaccine (PCV13)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. |
| Standard prophylaxis | Active comparator | Drug: Standard Antibacterial ProphylaxisPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Vaccination group |
| Standard Antibacterial ProphylaxisLevofloxacin 500 mg once daily during the median four cycles of treatment by novel agents. | Drug | Standard prophylaxis |
Primary outcome
Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents.
Time frame: One year
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Background: PubMed 28854147Wallington-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.
- Background: PubMed 26150022Satlin 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.
- Background: PubMed 25212681Jung 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.
- Background: PubMed 25870329Cordonnier 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.
- Results publication: PubMed 32418789Stoma 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.
- Derived from this study: PubMed 40396505Zorger 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.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoly Uss, MD/PhD study chair
Minsk Scientific Practical Center of Surgery, Transplantation and Hematology, Belarus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccination with pneumococcal conjugate vaccine (PCV13) and Standard Antibacterial Prophylaxis in people with Multiple Myeloma and Pneumococcal Infection, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619252, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.