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

Multiple Myeloma Clinical Trial

— CLARITY  

Official title:

CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma (CLARITY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190525
• Other study ID #: QoL-MM1016
• Status: Recruiting
• Start date: November 13, 2017
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Francesca Tartaglia
• Phone: +39 06441639838
• Email: f.tartaglia[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Quality of life questionnaires
QLQ-C30

Locations

Country	Name	City	State
Italy	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	Firenze
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
United Kingdom	London North West Healthcare Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To devise a patient-centered frailty score for RRMM patients.		30 months from study entry
Secondary	To investigate the prognostic value of the frailty score in the setting of RRMM.		30 months from study entry
Secondary	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
Secondary	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
Secondary	To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics.		30 months from study entry
Secondary	To assess and compare the baseline self-reported EORTC QLQ-C30 fatigue scale ratings, between those RRMM patients who had received only one line of treatment (1 line) versus more than one line of treatment (>1 line) at study entry		30 months from study entry