NCT03188536 · REGISTRY CONDITION SEARCH

Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2020-10-12

The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis

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outcome · POSTED

Percentage of MM Participants Categorized by Clinical Variables at Diagnosis

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outcome · POSTED

Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode

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outcome · POSTED

Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode

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outcome · POSTED

Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse

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outcome · POSTED

Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30

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outcome · POSTED

HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score

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outcome · POSTED

HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)

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outcome · POSTED

Percentage of Participants With Health Care Resource Utilization (HU)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Have a diagnosis of MM and has received at least one previous treatment line. * Have experienced symptomatic relapse and/or refractory disease in the 6 months before the study. * Has continued in follow-up at the time of the study visit. * Is currently treated in the site who have clinical records available. * Is capable of understanding and completing the questions in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and EORTC Multiple Myeloma Module (QLQ-MY20) questionnaires. Exclusion Criteria: • Participants who do not agree to participate in the study or who do not give written informed consent.
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: Participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study.

Treatment arms and interventions

arm Groups

description
Adult participants with a diagnosis of MM who received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
intervention Names
Other: No Intervention
label
Multiple Myeloma (MM) Participants

interventions

arm Group Labels
Multiple Myeloma (MM) Participants
description
As it was an observational study, no intervention was administered in this study.
name
No Intervention
type
OTHER

Study design

observational Model: COHORT
time Perspective: RETROSPECTIVE

Enrollment

count: 282
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Sociodemographic variables included age(in years), sex(male or female), body mass index(BMI), residence(rural or urban), educational level(illiterate,no studies(can only read/write),primary studies,secondary studies,higher studies), work status(unemployed,active employment,temporarily/ permanently disabled, retired, other), cohabitation(lives-alone,with relatives,alone with help from a caregiver), need for financial assistance (yes/no), degree of dependence(independent,dependent:grade I-requires help to perform activities of daily living \[ADL\] at least once a day,grade II-needs help to perform ADLs 2 or 3 times a day or grade III-needs help to perform ADLs several times a day), healthy habits (high\[jogging;climbing;cycling;swimming;sports;intensive work;moving \>20 kg loads\], moderate\[walking;dancing;domestic chores;sports with children,walking house pets;general construction work;moving \<20 kg loads\] physical activity or inactive, smoking habit (yes/no), alcohol use (yes/no).
measure
Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
time Frame
Day 1
description
Clinical variables at Diagnosis included age,MM type(heavy/light chain/Bence-Jones protein), international staging system(ISS),disease stage(I:low risk,β2-Microglobulin\<3.5mg/L and albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-Microglobulin≥5.5mg/L),calcium,renal insufficiency,anemia or bone lesions(CRAB) signs(serum calcium\>0.25mmol/L upper limit of normal,renal failure-creatinine clearance\<40mL/min/serum creatinine\>117μmol/L, anemia:reduction of hemoglobin(Hb)\>2g/dL below lower limit of normal or Hb\<10g/dL,bone lesions 1/more osteolytic lesion,cytogenetic abnormalities(t\[4;14\],t\[11;14\],t\[14;16\],t\[14;20\],t\[6;14\],trisomies,d\[17p\],g\[1q\]/others), risk according to cytogenetic profile(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), eastern cooperative oncology group(ECOG) status (0:fully active,1:restricted physical activity,2:ambulatory,unable to carry out any work,3:capable of limited selfcare,4:completely disabled,5:dead).
measure
Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
time Frame
Day 1
description
Clinical variables include date of latest symptomatic relapse and/or refractory episode, ISS disease stage, CRAB signs, other clinical variables (plasmacytomas: medullary or extramedullary, diffuse osteopenia, fractures, neurological symptoms, infections, concomitant diseases like diabetes, neuropathy, chronic obstructive pulmonary disease (COPD), cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders, cytogenetic abnormalities, risk according to cytogenetic profile at relapse(standard:trisomies,t\[11;14\];t\[6;14\],intermediate:t\[4;14\],g\[1q\], high:d\[17p\],t\[14;16\],t\[14;20\],other), treatment started after latest symptomatic relapse and/or refractory episode.
measure
Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
time Frame
Day 1

secondary Outcomes

description
Clinical and Sociodemographic variables categorized by treatment selection(immunomodulators\[IMiDs\],proteasome inhibitor\[PI\]+IMiDs,PI,monoclonal antibodies\[mAb\]): Age,sex(male/female),prior treatment lines(0,1,2,3 or more),prior relapses(0,1,2,3 or more),ISS disease stage(I:low risk,β2-Microglobulin\<3.5mg/L,albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-Microglobulin≥5.5mg/L),CRAB signs(serum calcium\>0.25mmol/L upper limit of normal,renal failure-creatinine clearance\<40mL/min/serum creatinine\>117μmol/L,anemia:reduction of hemoglobin(Hb)\>2g/dL below lower limit of normal or Hb\<10g/dL,bone lesions 1/more osteolytic lesion),risk according to cytogenetic profile(standard:trisomies,t\[11;14\];t\[6;14\];high:d\[17p\],t\[14;16\],t\[14;20\],other),other clinical variables:medullary/extramedullary plasmacytomas,osteopenia,fractures,neurological symptoms,infections,concomitant diseases:diabetes, neuropathy, COPD, cardiovascular disease, liver failure, psychiatric, neurological disorders.
measure
Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
time Frame
Day 1
measure
Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse
time Frame
Day 1
description
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale with a recall period of the previous week. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
measure
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
time Frame
Day 1
description
The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.
measure
HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
time Frame
Day 1
description
The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. Spanish Translated Version of EORTC Multiple Myeloma Module included 4 factors, each factor corresponds to questions related to the particular component of the scale. Factor I indicate symptoms. Factor II indicates future perspectives. Factor III indicate adverse effects of the treatment. Factor IV indicates adverse effects of the treatment and body image. Each of these factors were used for the clinical validity of the scale.
measure
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
time Frame
Day 1
description
Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.
measure
Percentage of Participants With Health Care Resource Utilization (HU)
time Frame
Day 1

Full study description

brief Summary: The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
detailed Description: Adult participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study. The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected. The study will enroll approximately 350 patients. This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.

Source references

references

citation
Dachs LR, Gaisan CM, Bustamante G, Lopez SG, Garcia EG, Persona EP, Gonzalez-Calle V, Auzmendi MS, Perez JMA, Gonzalez Montes Y, Rios Tamayo R, de Miguel Llorente D, Bernal LP, Mayol AS, Caro CC, Grande M, Fernandez-Nistal A, Naves A, Miguel EMOS. Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study. Leuk Lymphoma. 2023 Nov-Dec;64(11):1847-1856. doi: 10.1080/10428194.2023.2240922. Epub 2023 Aug 4.
pmid
37539698
type
DERIVED
citation
Ocio EM, Montes-Gaisan C, Bustamante G, Garzon S, Gonzalez E, Perez-Persona E, Gonzalez-Calle V, Sirvent M, Arguinano JM, Gonzalez Y, Rios R, de Miguel D, Grande M, Fernandez-Nistal A, Naves A, Rosinol L. Real-World Health Care Services Utilization Associated With the Management of Patients With Relapsed and Refractory Multiple Myeloma in Spain: The CharisMMa Study. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e341-e347. doi: 10.1016/j.clml.2023.07.006. Epub 2023 Jul 15.
pmid
37517875
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice