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Clinical Trials in Italy / NCT03190525
Active, not recruiting Observational

Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma

NCT03190525 · tracked via the Priya Life Science Italy tracker
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase
Observational
Started
2017-11-13
Last updated
2025-06-12

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Quality of life questionnaires

Quality of life questionnaires: QLQ-C30

Study summary

The primary objective is overall survival (OS) as predicted by baseline self-reported EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) fatigue scale ratings, independently from other prognostic factors for OS in multiple myeloma (MM), including the clinically-based prognostic frailty score.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * MM patients who have received at least 1 prior line of therapy and are considered as RRMM according to IMWG criteria. * Adult patients (≥ 18 years old). * Written informed consent provided. * Patients who have been enrolled onto other study therapy protocols are also eligible. * Having a full baseline PRO evaluation completed. * All data a available to calculate the frailty score. Exclusion Criteria: * Having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent. * Having reported any grade ≥3 adverse event within two weeks prior to study entry. * Having received more than 5 lines of therapies.

Primary outcome measure(s)

  • The primary objective is overall survival (OS) as predicted by baseline self-reported EORTC QLQ-C30 fatigue scale ratings, independently from other prognostic factors for OS in MM, including the clinically-based prognostic frailty score. — 30 months from study entry

Trial sites (35)

FacilityCityRegionStatus
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI Ancona Italy
S. Orsola Malpighi Bologna Italy
Divisione di Ematologia Ospedale A. Perrino Brindisi Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO Cagliari Italy
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi Catania Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" Catania Italy
Unità Operativa Oncologia Medica - A.O. Pugliese Ciaccio Catanzaro Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi Cona Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza Cosenza Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano Florence Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Lecce Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina Messina Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza Messina Italy
UO Ematologia - AOU Policlinico di Modena Modena Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Novara Italy
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani Pagani Italy
U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone" Palermo Italy
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano Parma Italy
UOS di Ematologia Servizio di Immunoematologia e medicina Trasfusionale Azienda Sanitaria Provinciale 7 Ragusa Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Reggio Emilia Italy
Ospedale "Infermi" Rimini Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia Roma Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Roma Italy
Divisione Ematologia - Università Campus Bio-Medico Roma Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Roma Italy
Università degli Studi - Policlinico di Tor Vergata Roma Italy
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3 Rossano Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
Ematologia - Dipartimento di Medicina Clinica e Sperimentale Sassari Italy
U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte" Siena Italy
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati Taranto Italy
A.O. Santa Maria - Terni S.C Oncoematologia Terni Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino" Torino Italy
Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore Trieste Italy
London North West Healthcare Trust London United Kingdom

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Other trials for the same condition

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant Recruiting
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma Recruiting
Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients Active, not recruiting
European Myeloma Network (EMN) Sample Project Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03190525 on ClinicalTrials.gov ↗ ← All trials in Italy