Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström's Macroglobulinemia and in IgM-MGUS

Waldenstrom Macroglobulinemia Clinical Trial

— FIL_BIOWM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03521596
• Other study ID #: FIL_BIOWM
• Status: Active, not recruiting
• Start date: August 28, 2018
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2025
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Active HBV, HCV or HIV infection (antiHBc+ patients with undetectable HBV-DNA are eligible to the study)

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Other:
• MRD and clonal evolution
Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques

Locations

Country	Name	City	State
Italy	SOS Ematologia Ospedale C. Massaia	Asti
Italy	IRCCS Istituto Tumori Giovanni Paolo II - UOC Ematologia	Bari
Italy	Divisione di Ematologia Ospedale Niguarda	Milano	MI
Italy	AOU Università degli Studi della Campania Luigi Vanvitelli	Napoli
Italy	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova
Italy	A.O. Universitaria Di Parma	Parma
Italy	Ematologia Policlinico San Matteo	Pavia
Italy	AO Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia
Italy	Ospedale degli Infermi di Rimini	Rimini
Italy	Policlinico A. Gemelli Università Cattolica del Sacro Cuore	Roma
Italy	UOC Ematologia, AOU Senese	Siena
Italy	A.O. Città della Salute e della Scienza Ematologia Universitaria	Torino
Italy	Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - PO S. Maria della Misericordia	Udine
Italy	Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	22 months