Waldenstrom MacroglobulinemiaFIL_BIOWMNCT03521596
Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS
An observational study of Waldenstrom Macroglobulinemia, run by Fondazione Italiana Linfomi - ETS at 15 sites in 2 countries.
Trial summary
Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia
- What is being tested?
- MRD and clonal evolution
- How many people
- 300 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 28 Aug 2018to 2 Oct 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include either IgM-MGUS, asymptomatic WM or symptomatic WM patients requiring treatment. Patients in need of therapy will be treated according to recently published guidelines [49]. Patients treated with new agents, including the BTK inhibitor Ibrutinib, will be included. Patient enrolled retrospectively will constitute the learning cohort of the study, while those enrolled prospectively will constitute the validation cohort).
Who may be able to join
- Diagnosis of IgM monoclonal gammopathy of undetermined significance (Ig-MGUS) or Waldenström's Macroglobulinemia (WM) according to criteria established at the second International Workshop on Waldenström's Macroglobulinemia [1]
- Age ≥ 18 years
- Previously untreated patients (only for the prospective cohort)
- Symptomatic or asymptomatic disease
- Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)
Who cannot join
- Active HBV, HCV or HIV infection (antiHBc+ patients with undetectable HBV-DNA are eligible to the study)
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Italy14 sites
SOS Ematologia Ospedale C. Massaia
Asti, 14100
IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia
Bari, 70124
Divisione di Ematologia Ospedale Niguarda
Milan, MI
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova, 35128
A.O. Universitaria Di Parma
Parma, 43126
Ematologia Policlinico San Matteo
Pavia, 27100
AO Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
Ospedale degli Infermi di Rimini
Rimini, 47924
Policlinico A. Gemelli Università Cattolica del Sacro Cuore
Roma, 00168
UOC Ematologia, AOU Senese
Siena, 53100
A.O. Città della Salute e della Scienza Ematologia Universitaria
Torino
Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia
Udine, 33100
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, 21100
Spain1 site
Hematology Department, Laboratory of Molecular Biology and HLA typing, University Hospital of Salamanca
Salamanca
About this study
Official title: Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance
Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques.
Read the detailed description
Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative PCR (RT-qPCR), digital droplet PCR (dd-PCR) and NGS, in order to: evaluate the mutational status on genomic DNA or cell-free DNA and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and MRD monitoring.
- Conditions
- Waldenstrom Macroglobulinemia
- Being tested
- MRD and clonal evolution
- Keywords
- IgM monoclonal gammopathy, Waldenström's Macroglobulinemia, Minimal residual disease, Clonal evolution
- Medical subject headings
- Waldenstrom Macroglobulinemia, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD and clonal evolutionOther
Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques
| Study group | Role | What they receive |
|---|---|---|
| Patient enrolled | Part of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample) Receives: Other: MRD and clonal evolution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mutation
To demonstrate that the rate of mutations of MYD88 (L265P) and/or CXCR4 (S338X) detected in peripheral blood and/or urine show a negligible difference with the rate of mutations detected in bone marrow samples (BM, gold standard)
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start28 Aug 2018
- Primary completion6 Oct 2020
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom MacroglobulinemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marzia Varettoni, Principal investigator, Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521596
- Sponsor's protocol ID
- FIL_BIOWM
- Acronym
- FIL_BIOWM
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2018
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnostics and Monitoring of Minimal Residual Disease and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM Monoclonal Gammopathy of Undetermined Significance
- ClinicalTrials.gov ID
- NCT03521596
- Acronym / sponsor ID
- FIL_BIOWM / FIL_BIOWM
- Conditions
- Waldenstrom Macroglobulinemia
- Keywords
- IgM monoclonal gammopathy, Waldenström's Macroglobulinemia, Minimal residual disease, Clonal evolution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 11 May 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.
Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques.
Detailed description
Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques such as flow cytometry, real time quantitative PCR (RT-qPCR), digital droplet PCR (dd-PCR) and NGS, in order to: evaluate the mutational status on genomic DNA or cell-free DNA and compare the results to assess the most reliable source for mutation studies; perform and compare molecular and flow cytometry analyses on bone marrow, peripheral blood (both analyses), plasma and urine samples (only molecular analysis) to assess the best source for diagnosis and MRD monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient enrolled | – | Other: MRD and clonal evolutionPart of the patients will be retrospectively enrolled (learning sample) and part prospectively (validation sample) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include either IgM-MGUS, asymptomatic WM or symptomatic WM patients requiring treatment. Patients in need of therapy will be treated according to recently published guidelines [49]. Patients treated with new agents, including the BTK inhibitor Ibrutinib, will be included. Patient enrolled retrospectively will constitute the learning cohort of the study, while those enrolled prospectively will constitute the validation cohort).
Key inclusion criteria (5 listed)
- Diagnosis of IgM monoclonal gammopathy of undetermined significance (Ig-MGUS) or Waldenström's Macroglobulinemia (WM) according to criteria established at the second International Workshop on Waldenström's Macroglobulinemia [1]
- Age ≥ 18 years
- Previously untreated patients (only for the prospective cohort)
- Symptomatic or asymptomatic disease
- Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)
Key exclusion criteria (1 listed)
- Active HBV, HCV or HIV infection (antiHBc+ patients with undetectable HBV-DNA are eligible to the study)
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 |
|---|---|---|
| MRD and clonal evolutionPatient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques | Other | Patient enrolled |
Primary outcome
Rate of mutation
Time frame: 22 months
To demonstrate that the rate of mutations of MYD88 (L265P) and/or CXCR4 (S338X) detected in peripheral blood and/or urine show a negligible difference with the rate of mutations detected in bone marrow samples (BM, gold standard)
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 27 Aug 2026.
Related trials for Waldenstrom Macroglobulinemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
Waldenstrom Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
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.
Marzia Varettoni principal investigator
Pavia - IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Waldenstrom Macroglobulinemia, run by Fondazione Italiana Linfomi - ETS at 15 sites in 2 countries.
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 5 inclusion and 1 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Spain. 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?
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?
Rate of mutation (time frame: 22 months). 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 27 Aug 2026.