Multiple MyelomaNCT05844033
Biomarker for Infection Risk in CLL and MM
An observational study of Multiple Myeloma and Chronic Lymphocytic Leukemia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- What is being tested?
- Screening
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple Myeloma.
Who may be able to join
- Adults ≥18 years of age.
- Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
- Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.
Who cannot join
- Subjects must not have received IVIG administration within 6 calendar months of registration or have planned immunoglobulin replacement therapy by treating investigator at time of registration.
- Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0.
- Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
- Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
- Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
- Subjects must have no known history of HIV, primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication at time of registration. Treatment for CLL/SLL or MM, CLL/SLL related autoimmune phenomenon, or physiologic dosing of corticosteroids (5mg/day prednisone/equivalent or lower) is permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
Read the detailed description
The goal of this research study is to identify an antigen-specific antibody profiling biomarker associated with increased risk of any infections in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
Research procedures including screening for eligibility, clinic visits, and blood tests.
This involves performing blood tests which detect antibodies directed against specific pathogens and measure their functional capacity, and collecting information about outcomes in patients.
Participation in this research study is expected to last 2 years.
It is expected that about 150 people CLL or MM will take part in this research study, and this will predominantly include people with CLL/SLL.
Takeda is supporting this research study by providing funding.
- Conditions
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- Being tested
- Screening
- Keywords
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- Medical subject headings
- Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Blood tests
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia and Multiple Myeloma Participants | 150 participants will be screened for an antigen-specific antibody profiling biomarker that is associated with an increased risk of any infections.
Study procedures include in-person or virtual appointments every 3 months for 2 years, some of which will also include bloodwork:
* In-person or virtual appointments with study staff for months 4, 10, 16, and 22 Day 1.
* In-person or virtual appointments with study staff for months 7, 13, 19, and 25 Day 1 with blood tests. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of All-Grade Infections For All Participants
Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for all participants.
Measured: up to 2 years
Secondary outcomes (7)
Number of Grade ≥3 Infections For All Participants
Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for all participants.
Measured: up to 2 years
Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants
Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for CLL/SLL participants.
Measured: Up to 2 years
Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants
Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for CLL and SLL participants.
Measured: up to 2 years
Number of All-Grade Infections for Multiple Myeloma (MM) Participants
Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for MM participants.
Measured: up to 2 years
Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants
Defined as the number of Grade ≥3 infections per person-years per CTCAE version 5.0 for MM participants.
Measured: up to 2 years
Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.
Defined as any incident in which immunoglobulin replacement therapy is administered to an participant who develops symptomatic hypogammaglobulinemia with Immunoglobulin G <600mg/dL and either 1) ≥2 associated infections within a 6-month period, or 2) any grade ≥3 associated infection.
Measured: Up to 2 years
Proportion of patients who develop asymptomatic hypogammaglobulinemia in CLL/SLL or MM.
Defined as the proportion of all participants who develop symptomatic hypogammaglobulinemia.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Jacob Soumerai, MD, Massachusetts General Hospital
- Investigators
- Jacob Soumerai, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844033
- Sponsor's protocol ID
- 23-105
- Status last verified
- May 2026
- First submitted
- 13 Apr 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Infection Risk in Chronic Lymphocytic Leukemia and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05844033
- Acronym / sponsor ID
- 23-105
- Conditions
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- Keywords
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 May 2023 (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.
The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
Detailed description
The goal of this research study is to identify an antigen-specific antibody profiling biomarker associated with increased risk of any infections in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).
Research procedures including screening for eligibility, clinic visits, and blood tests.
This involves performing blood tests which detect antibodies directed against specific pathogens and measure their functional capacity, and collecting information about outcomes in patients.
Participation in this research study is expected to last 2 years.
It is expected that about 150 people CLL or MM will take part in this research study, and this will predominantly include people with CLL/SLL.
Takeda is supporting this research study by providing funding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia and Multiple Myeloma Participants | – | Other: Screening150 participants will be screened for an antigen-specific antibody profiling biomarker that is associated with an increased risk of any infections. Study procedures include in-person or virtual appointments every 3 months for 2 years, some of which will also include bloodwork: * In-person or virtual appointments with study staff for months 4, 10, 16, and 22 Day 1. * In-person or virtual appointments with study staff for months 7, 13, 19, and 25 Day 1 with blood tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple Myeloma.
Key inclusion criteria (3 listed)
- Adults ≥18 years of age.
- Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
- Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.
Key exclusion criteria (6 listed)
- Subjects must not have received IVIG administration within 6 calendar months of registration or have planned immunoglobulin replacement therapy by treating investigator at time of registration.
- Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0.
- Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
- Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
- Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
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 |
|---|---|---|
| ScreeningBlood tests | Other | Chronic Lymphocytic Leukemia and Multiple Myeloma Participants |
Primary outcome
Number of All-Grade Infections For All Participants
Time frame: up to 2 years
Defined as the number of All-Grade infections per person-years per CTCAE version 5.0 for all participants.
7 secondary outcomes
Number of Grade ≥3 Infections For All Participants
Time frame: up to 2 years
Number of All-Grade Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) Participants
Time frame: Up to 2 years
Number of Grade ≥3 Infections for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Participants
Time frame: up to 2 years
Number of All-Grade Infections for Multiple Myeloma (MM) Participants
Time frame: up to 2 years
Number of Grade ≥3 Infections for Multiple Myeloma (MM) Participants
Time frame: up to 2 years
Proportion of patients who develop symptomatic hypogammaglobulinemia in CLL/SLL or MM.
Time frame: Up to 2 years
Proportion of patients who develop asymptomatic hypogammaglobulinemia in CLL/SLL or MM.
Time frame: Up to 2 years
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 19 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jacob Soumerai, MD principal investigator
Massachusetts General Hospital
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 Multiple Myeloma and Chronic Lymphocytic Leukemia, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 6 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 19 May 2026. 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 United States. 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?
Number of All-Grade Infections For All Participants (time frame: up to 2 years). 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 19 May 2026.