MyelomaNCT06944119
Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
An observational study of Myeloma and Lymphoma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being… Read more about this study
- Who is it for?
- Ages 60 years and older
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2025to Mar 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 years and older diagnosed with multiple myeloma, lymphoma, CLL, myelodysplastic syndrome, and acute leukemia who are scheduled to receive the RSV vaccine.
Who may be able to join
- Patients aged 60 years and older
- Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia
Who cannot join
- Patients who have been previously vaccinated against RSV
- Patients who have experienced a severe reaction to any vaccine in the past
Trial locations and contacts
1 site in 1 country.
About this study
A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in TASMC clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.
Read the detailed description
participants 250 Single-center Research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. This estimate is based on a study published in the NEJM which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. the investigators estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received.
The study will include patients with chronic lymphocytic leukemia (CLL), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. The investigatorsexpect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.
- Conditions
- Myeloma, Lymphoma, CLL, Myelodysplastic Syndrome, Leukemia Acute Myeloid - AML
- Medical subject headings
- Neoplasms, Plasma Cell, Lymphoma, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine
The response rate Is expected to be 60-70%
Measured: Up to 45 days post-vaccination
Secondary outcomes (3)
To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events
The safety of the vaccine will be evaluated in hemato-oncological patients through the collection of adverse events (AEs) and serious adverse events (SAEs) up to 45 days post-vaccination.
Measured: Up to 45 days post-vaccination
To identify factors predicting success/failure in achieving an antibody response to the vaccine.
- All adverse events occurring within 30 days following vaccination.
- Grade≥3 adverse events occurring within 30 days following vaccination.
Measured: Up to 1 year
To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.
We will assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period by collecting data on RSV infections during the year following vaccination.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start20 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Irit Avivi, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944119
- Sponsor's protocol ID
- 0646-24-TLV
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia
- ClinicalTrials.gov ID
- NCT06944119
- Acronym / sponsor ID
- 0646-24-TLV
- Conditions
- Myeloma, Lymphoma, CLL, Myelodysplastic Syndrome, Leukemia Acute Myeloid - AML
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Apr 2025 (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.
A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in TASMC clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.
Detailed description
participants 250 Single-center Research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. This estimate is based on a study published in the NEJM which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. the investigators estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received.
The study will include patients with chronic lymphocytic leukemia (CLL), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. The investigatorsexpect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 years and older diagnosed with multiple myeloma, lymphoma, CLL, myelodysplastic syndrome, and acute leukemia who are scheduled to receive the RSV vaccine.
Key inclusion criteria (2 listed)
- Patients aged 60 years and older
- Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia
Key exclusion criteria (2 listed)
- Patients who have been previously vaccinated against RSV
- Patients who have experienced a severe reaction to any vaccine in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine
Time frame: Up to 45 days post-vaccination
The response rate Is expected to be 60-70%
3 secondary outcomes
To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events
Time frame: Up to 45 days post-vaccination
To identify factors predicting success/failure in achieving an antibody response to the vaccine.
Time frame: Up to 1 year
To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Irit Avivi, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma and Lymphoma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. 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 Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine (time frame: Up to 45 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.