Clinical trial · Observational
Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma
CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma (CLARITY)
NCT03190525CI-TRIAL-00090942CLARITYactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Multiple Myeloma patients
- interventionNames
- Other: Quality of life questionnaires
Primary outcomes (1)
- 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.
- timeFrame
- 30 months from study entry
Secondary outcomes (6)
- measure
- To devise a patient-centered frailty score for RRMM patients.
- timeFrame
- 30 months from study entry
- measure
- To investigate the prognostic value of the frailty score in the setting of RRMM.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDKrepper 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
- DERIVEDEfficace 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