PRAME: Spanish Registry of Patients With IgM Monoclonal Gammopathies

Sponsor

Fundación Española de Hematología y Hemoterapía (Other)

Overall Status

Recruiting

CT.gov ID

NCT05093153

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disorder which is defined by bone marrow infiltration by small lymphocytes, lymphoplasmacytoid and plasma cells together with the presence of a detectable monoclonal immunoglobulin M (IgM).The clinical presentation of WM is variable. Symptoms can be related to tumor infiltration, or they can be related to the monoclonal IgM component. The therapeutic options are heterogeneous and there are no well-established in both first line or relapse/refractory settings. In Spain, the incidence of MGUS-IgM and WM in the last decade is unknown.

The aims of this retrospective, observational, multicentric study is:

To develop a national registry of patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance -IgM in Spain in the past 30years.
To evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with WM
To help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in Spain.

Methods:

The investigators will collect data from the patient clinical files after prior Informed Consent providing from patients with diagnosis of MGUS-IgM and WM in the past 30 years in Spain, according to the WHO classification of lymphoid tumors (2008) revised in 2016. Data from patients not able to provide IC (i.e., already dead patients) will be included only after the permission of the ethics review board.

The collected data will be included in a database of the Spanish Myeloma and Lymphoma Intergroup (SMALI) team created ad-hoc by the Spanish Society of Hematology and Hemotherapy (SEHH). Each principal investigator in each center will conduct their technical supervision. The evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the International Waldenström's Macroglobulinemia Group.

Condition or Disease	Intervention/Treatment	Phase
Waldenstrom Macroglobulinemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Waldenström's macroglobulinemia cohort patient Adult patients diagnosed with Waldenström's Macroglobulinemia

Outcome Measures

Primary Outcome Measures

Overall survival [through study completion, an average of 4 years]
Overall survival evaluation from the date of diagnosis to the death of the patient due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Age ≥18 years
Patients having a confirmed diagnosis of either in the las 30 years:
Monoclonal Gammopathy of uncertain significance -IgM
Asymptomatic Waldenström's macroglobulinemia
Symptomatic Waldenström's macroglobulinemia

Exclusion Criteria:

Other subtypes of Lymphoproliferative diseases.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Vital Álvarez-Buylla	Mieres	Asturias	Spain
2	ICO Badalona - Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
3	Hospital Sant Joan de Déu de Manresa	Manresa	Barcelona	Spain
4	Hospital Parc Taulí	Sabadell	Barcelona	Spain
5	Hospital Marques de Valdecilla	Santander	Cantabria	Spain
6	Hospital Son Llatzer	Palma	Islas Baleares	Spain
7	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	La Coruña	Spain
8	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain
9	Hospital Costa del Sol	Marbella	Málaga	Spain
10	Hospital Clínic de Barcelona	Barcelona		Spain
11	Hospital del Mar	Barcelona		Spain
12	Hospital Vall d'Hebron	Barcelona		Spain
13	Hospital Universitario Reina Sofía	Córdoba		Spain
14	CAU de León	León		Spain
15	Hospital Universitario Arnau de Vilanova	Lleida		Spain
16	Hospital Universitario Fundación Jimenez Diaz	Madrid		Spain
17	Hospital Universitario Puerta de Hierro	Madrid		Spain
18	Hospital Universitario Ramón y Cajal	Madrid		Spain
19	Hospital Universitario Virgen de la Victoria	Málaga		Spain
20	CAU de Salamanca	Salamanca		Spain
21	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife		Spain
22	Hospital Clínico de Valencia	Valencia		Spain
23	Hospital La Fe de Valencia	Valencia		Spain
24	Hospital Universitario Doctor Peset	Valencia		Spain
25	Hospital Clínico Universitario Lozano Blesa	Zaragoza		Spain

Sponsors and Collaborators

Fundación Española de Hematología y Hemoterapía

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundación Española de Hematología y Hemoterapía

ClinicalTrials.gov Identifier:

NCT05093153

Other Study ID Numbers:

PRAME

First Posted:

Oct 26, 2021

Last Update Posted:

Jul 6, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia

Study Results

No Results Posted as of Jul 6, 2022