Multiple MyelomaCLARITYNCT03190525
Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma
An observational study of Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 35 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Quality of life questionnaires
- How many people
- 530 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 13 Nov 2017to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
Italy34 sites
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona
S. Orsola Malpighi
Bologna
Divisione di Ematologia Ospedale A. Perrino
Brindisi
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
Catania
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Unità Operativa Oncologia Medica - A.O. Pugliese Ciaccio
Catanzaro
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Cosenza
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Messina
UO Ematologia - AOU Policlinico di Modena
Modena
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani
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
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano
Parma
UOS di Ematologia Servizio di Immunoematologia e medicina Trasfusionale Azienda Sanitaria Provinciale 7
Ragusa
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Ospedale "Infermi"
Rimini
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Divisione Ematologia - Università Campus Bio-Medico
Roma
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
Università degli Studi - Policlinico di Tor Vergata
Roma
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
Rossano
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari
U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte"
Siena
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto
A.O. Santa Maria - Terni S.C Oncoematologia
Terni
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino
Struttura Complessa II Medicina - Ematologia - Centro di Riferimento Ematologico - Ospedale Maggiore
Trieste
About this study
Official title: CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma (CLARITY)
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.
Read the 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
- Being tested
- Quality of life questionnaires
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
QLQ-C30
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma patients | Not described Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months from study entry
Secondary outcomes (6)
To devise a patient-centered frailty score for RRMM patients.
Measured: 30 months from study entry
To investigate the prognostic value of the frailty score in the setting of RRMM.
Measured: 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.
Measured: 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).
Measured: 30 months from study entry
To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics.
Measured: 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
Measured: 30 months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start13 Nov 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Teresa Petrucci, MD, Principal investigator, Roma SapienzaFabio Efficace, Study chair, GIMEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190525
- Sponsor's protocol ID
- QoL-MM1016
- Acronym
- CLARITY
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2017
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40472573Efficace 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.
PubMed 29914509
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma (CLARITY)
- ClinicalTrials.gov ID
- NCT03190525
- Acronym / sponsor ID
- CLARITY / QoL-MM1016
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma patients | – | Other: Quality of life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnairesQLQ-C30 | Other | Multiple Myeloma patients |
Primary outcome
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.
Time frame: 30 months from study entry
6 secondary outcomes
To devise a patient-centered frailty score for RRMM patients.
Time frame: 30 months from study entry
To investigate the prognostic value of the frailty score in the setting of RRMM.
Time frame: 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.
Time frame: 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).
Time frame: 30 months from study entry
To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics.
Time frame: 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
Time frame: 30 months from study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 40472573Krepper 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.
- Derived from this study: PubMed 29914509Efficace 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Teresa Petrucci, MD principal investigator
Roma Sapienza
Fabio Efficace study chair
GIMEMA Foundation
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 months from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03190525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.