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

NCT ID: NCT03190525

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2025-12-31

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.

Detailed Description

While quality of life (QoL) and other types of patient-reported Outcomes (PROs) can be crucial in the management of RRMM patients, a perusal of the literature indicates a dearth of information in this area. PRO is defined by the US Food and Drug Administration (FDA) as "a measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient's response. Until now the few studies that have included PRO data have been conducted in newly diagnosed MM patients enrolled in randomized controlled trials (RCTs).

For the purpose of this protocol, we have conducted a systematic review of PRO studies conducted in RRMM patients receiving treatments with either Imunomodulatory agents (IMiDs) or Proteasome inhibitors (PIs). The search was conducted for studies published from January, 1990 to July, 2015 and yielded only eight studies published within this timeframe. Three studies dealt with bortezomib based regimens, two with thalidomide, and the remaining studies with carfilzomib, pomalidomide, and lenalidomide. In all these studies PROs were considered as secondary outcomes and in four this was analyzed in the context of RCTs.

Despite enhanced disease control, none of the current novel agents, either IMiDs or PIs are free of significant toxicities, which frequently persist after completing treatment and continue to impair patient's daily functioning over the long-term period. Also, it is important to consider the poor prognosis for many of these patients. For example, patients who fail first-line PIs or IMiDs have been shown to report an average life expectancy of 9 months from the time of becoming refractory to PIs and IMiDs. Maintaining a "good" or "acceptable" level of QoL and lowering symptom burden over the longest possible period of time is a main goal of treatment for RRMM patients. Therefore, considering the paucity of QoL evidence-base data, CLARITY is designed to expand on some key understudied areas in this population that are broadly summarized in the next two paragraphs.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Myeloma patients

Quality of life questionnaires

Intervention Type: OTHER

QLQ-C30

Interventions

Quality of life questionnaires

QLQ-C30

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Teresa Petrucci, MD

Role: PRINCIPAL_INVESTIGATOR

Roma Sapienza

Fabio Efficace

Role: STUDY_CHAIR

GIMEMA Foundation

Locations

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

Countries

Italy; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40472573 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29914509 (View on PubMed)

Other Identifiers

QoL-MM1016

Identifier Type: -

Identifier Source: org_study_id