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

Multiple Myeloma Clinical Trial

Official title:

Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188536
• Other study ID #: RRMM-5012
• Secondary ID: TAK-MMR-2017-01
• Status: Completed
• Start date: July 26, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: September 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: January 30, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• No Intervention
As it was an observational study, no intervention was administered in this study.

Locations

Country	Name	City	State
Spain	Hospital Clinico de Barcelona	Barcelona	Cataluna
Spain	Hospital de Burgos	Burgos	Castilla Y Leon
Spain	H Universitario Puerta del Mar	Cadiz	Andalucia
Spain	H de Donosti	Donostia	Pais Vasco
Spain	H Universitario de Cabuenes	Gijon	Asturias
Spain	Hospital Doctor Trueta ICO Girona	Girona	Cataluna
Spain	H Virgen de las Nieves	Granada	Andalucia
Spain	H U de Guadalajara	Guadalajara	Castilla La Mancha
Spain	ICO Bellvitge	Hospitalet de Llobregat	Cataluna
Spain	Hospital Juan Ramon Jimenez	Huelva	Andalucia
Spain	H Jerez	Jerez de la Frontera	Andalucia
Spain	Hospital de Leon	Leon	Castilla Y Leon
Spain	Hospital Lucus Agusti	Lugo	Galicia
Spain	H 12 de Octubre	Madrid
Spain	H Infanta Leonor	Madrid
Spain	Hospital Costa del Sol	Marbella	Andalucia
Spain	H Son Espases	Palma	Islas Baleares
Spain	Hospital Son Llatzer	Palma	Islas Baleares
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital de Salamanca	Salamanca	Castilla Y Leon
Spain	H U Canarias	San Cristobal de La Laguna	Canarias
Spain	H Marques de Valdecilla	Santander	Cantabria
Spain	H Clinico Universitario de Santiago	Santiago de Compostela	Galicia
Spain	Complejo Asistencial de Segovia	Segovia	Castilla Y Leon
Spain	H. Nuestra Senora de Valme	Sevilla	Andalucia
Spain	H Universitari de Tarragona Joan XXIII	Tarragona	Cataluna
Spain	Complejo Hospitalario Toledo	Toledo	Castilla La Mancha
Spain	H Clinico de Valencia	Valencia
Spain	Hospital de Txagorritxu	Vitoria-Gasteiz	Pais Vasco
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza	Aragon

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis	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).	Day 1
Primary	Percentage of MM Participants Categorized by Clinical Variables at Diagnosis	Clinical variables at Diagnosis included age,MM type(heavy/light chain/Bence-Jones protein), international staging system(ISS),disease stage(I:low risk,ß2-Microglobulin<3.5mg/L and albumin=3.5g/dL,II:not stage I or III,III:high risk,ß2-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).	Day 1
Primary	Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode	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.	Day 1
Secondary	Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode	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,ß2-Microglobulin<3.5mg/L,albumin=3.5g/dL,II:not stage I or III,III:high risk,ß2-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.	Day 1
Secondary	Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse		Day 1
Secondary	Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30	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.	Day 1
Secondary	HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score	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.	Day 1
Secondary	HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)	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.	Day 1
Secondary	Percentage of Participants With Health Care Resource Utilization (HU)	Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.	Day 1