Clinical trial NCT03188536: Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
Official title: Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
timeFrame: Day 1
measure: Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
timeFrame: Day 1
measure: Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
timeFrame: 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
timeFrame: Day 1
measure: Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
timeFrame: Day 1
measure: HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
timeFrame: Day 1
measure: HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
timeFrame: Day 1
measure: Percentage of Participants With Health Care Resource Utilization (HU)
timeFrame: Day 1
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: H Universitario Puerta del Mar
state: Andalucia
city: Granada
country: Spain
facility: H Virgen de las Nieves
state: Andalucia
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
state: Andalucia
city: Jerez de la Frontera
country: Spain
facility: H Jerez
state: Andalucia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Andalucia
city: Sevilla
country: Spain
facility: H. Nuestra Senora de Valme
state: Andalucia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
state: Aragon
city: Gijon
country: Spain
facility: H Universitario de Cabuenes
state: Asturias
city: San Cristobal de La Laguna
country: Spain
facility: H U Canarias
state: Canarias
city: Santander
country: Spain
facility: H Marques de Valdecilla
state: Cantabria
city: Guadalajara
country: Spain
facility: H U de Guadalajara
state: Castilla La Mancha
city: Toledo
country: Spain
facility: Complejo Hospitalario Toledo
state: Castilla La Mancha
city: Burgos
country: Spain
facility: Hospital de Burgos
state: Castilla Y Leon
city: Leon
country: Spain
facility: Hospital de Leon
state: Castilla Y Leon
city: Salamanca
country: Spain
facility: Hospital de Salamanca
state: Castilla Y Leon
city: Segovia
country: Spain
facility: Complejo Asistencial de Segovia
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
state: Cataluna
city: Girona
country: Spain
facility: Hospital Doctor Trueta ICO Girona
state: Cataluna
city: Hospitalet de Llobregat
country: Spain
facility: ICO Bellvitge
state: Cataluna
city: Tarragona
country: Spain
facility: H Universitari de Tarragona Joan XXIII
state: Cataluna
city: Lugo
country: Spain
facility: Hospital Lucus Agusti
state: Galicia
city: Santiago de Compostela
country: Spain
facility: H Clinico Universitario de Santiago
state: Galicia
city: Palma
country: Spain
facility: H Son Espases
state: Islas Baleares
city: Palma
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Donostia
country: Spain
facility: H de Donosti
state: Pais Vasco
city: Vitoria-Gasteiz
country: Spain
facility: Hospital de Txagorritxu
state: Pais Vasco
city: Madrid
country: Spain
facility: H Infanta Leonor
city: Madrid
country: Spain
facility: H 12 de Octubre
city: Valencia
country: Spain
facility: H Clinico de Valencia
Study officials:
affiliation: Takeda
name: Medical Monitor Clinical Science
role: STUDY_DIRECTOR
References: