Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Other: Quality of life questionnaires
- Registration Number
- NCT03190525
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 520
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Multiple Myeloma patients Quality of life questionnaires -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To investigate the prognostic value of the frailty score in the setting of RRMM. 30 months from study entry 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 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 assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics. 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 devise a patient-centered frailty score for RRMM patients. 30 months from study entry
Trial Locations
- Locations (34)
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
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
🇮🇹Catania, Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
🇮🇹Cagliari, Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
🇮🇹Messina, Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
🇮🇹Firenze, Italy
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano
🇮🇹Parma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
🇮🇹Roma, Italy
A.O. Santa Maria - Terni S.C Oncoematologia
🇮🇹Terni, Italy
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
🇮🇹Taranto, Italy
U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte"
🇮🇹Siena, Italy
London North West Healthcare Trust
🇬🇧London, United Kingdom
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
🇮🇹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
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, 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
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
🇮🇹Messina, Italy
UO Ematologia - AOU Policlinico di Modena
🇮🇹Modena, Italy
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
🇮🇹Pagani, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
🇮🇹Novara, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, 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
UOS di Ematologia Servizio di Immunoematologia e medicina Trasfusionale Azienda Sanitaria Provinciale 7
🇮🇹Ragusa, Italy
Ospedale "Infermi"
🇮🇹Rimini, 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
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
Università degli Studi - Policlinico di Tor Vergata
🇮🇹Roma, Italy