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

NCT03190525 | Active Not Recruiting

• 1 other identifier: QoL-MM1016
• Study Type: observational
• Target: 530
• Locations: 2 countries
• Sites: 35

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• To devise a patient-centered frailty score for RRMM patients.

  30 months from study entry

• To investigate the prognostic value of the frailty score in the setting of RRMM.

  30 months from study entry

• To investigate QoL over time (outcome measures: EORTC QLQ-C30 and QLQ-MY20) by type of treatment and examine factors that contribute the most in maintaining baseline QoL levels.

  30 months from study entry

• To investigate relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-MY20).

  30 months from study entry

• To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics.

  30 months from study entry

Study Arms (1)

Multiple Myeloma patients

Other: Quality of life questionnaires

Interventions

Quality of life questionnaires OTHER

QLQ-C30

Multiple Myeloma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Considering the observational nature of study and fact that we aim to provide data on RRMM patients from the real-world setting, we have set up very broad inclusion criteria. Patients enrolled in clinical trials are still eligible for this protocol. Possible participation in a clinical trial at the time of entry in this study will be recorded and used for sensitivity analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (35)

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

Ancona, Italy

Location

S. Orsola Malpighi

Bologna, Italy

Location

Divisione di Ematologia Ospedale A. Perrino

Brindisi, Italy

Location

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, Italy

Location

Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi

Catania, Italy

Location

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Catania, Italy

Location

Unità Operativa Oncologia Medica - A.O. Pugliese Ciaccio

Catanzaro, Italy

Location

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

Cona, Italy

Location

U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza

Cosenza, Italy

Location

Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano

Florence, Italy

Location

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, Italy

Location

Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

Messina, Italy

Location

U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza

Messina, Italy

Location

UO Ematologia - AOU Policlinico di Modena

Modena, Italy

Location

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

Pagani, Italy

Location

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

Location

Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano

Parma, Italy

Location

UOS di Ematologia Servizio di Immunoematologia e medicina Trasfusionale Azienda Sanitaria Provinciale 7

Ragusa, Italy

Location

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

Ospedale "Infermi"

Rimini, Italy

Location

Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia

Roma, Italy

Location

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

Roma, Italy

Location

Divisione Ematologia - Università Campus Bio-Medico

Roma, Italy

Location

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, Italy

Location

Università degli Studi - Policlinico di Tor Vergata

Roma, Italy

Location

Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3

Rossano, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, Italy

Location

U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte"

Siena, Italy

Location

U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati

Taranto, Italy

Location

A.O. Santa Maria - Terni S.C Oncoematologia

Terni, Italy

Location

Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"

Torino, Italy

Location

Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore

Trieste, Italy

Location

London North West Healthcare Trust

London, United Kingdom

Location

Related Publications (2)

• Krepper D, Sparano F, Giesinger JM, Gaidano G, Niscola P, Codeluppi K, Antonioli E, Califano C, Floro L, Annibali O, Fozza C, Tafuri A, Mazza P, Potenza L, Vignetti M, Cavo M, Petrucci MT, Efficace F. Assessing frailty in patients with relapsed/refractory multiple myeloma: A comparison between the patient-reported frailty phenotype and the International Myeloma Working Group frailty index. J Geriatr Oncol. 2025 Jul;16(6):102266. doi: 10.1016/j.jgo.2025.102266. Epub 2025 Jun 4.

  PMID: 40472573 DERIVED

• Efficace F, Boccadoro M, Palumbo A, Petrucci MT, Cottone F, Cannella L, Zamagni E, Niscola P, Kyriakou C, Caravita T, Offidani M, Mandelli F, Cavo M. A prospective observational study to assess clinical decision-making, prognosis, quality of life and satisfaction with care in patients with relapsed/refractory multiple myeloma: the CLARITY study protocol. Health Qual Life Outcomes. 2018 Jun 18;16(1):127. doi: 10.1186/s12955-018-0953-4.

  PMID: 29914509 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Teresa Petrucci, MD

  Roma Sapienza

  PRINCIPAL INVESTIGATOR

• Fabio Efficace

  GIMEMA Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: November 13, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

GB (1); IT (34)