A Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
QoLMMBuS
Observational Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
1 other identifier
observational
355
1 country
65
Brief Summary
Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this protocol can participate. The participating patients must sign an informed consent, which the investigator who will collect the study variables in an electronic case report form (eCRF) will provide to them. The investigators must recruit at least 450 patients in a 24-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
December 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedNovember 22, 2022
November 1, 2022
5.9 years
September 30, 2016
November 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Health-related quality of life (HRQoL)
This questionnaire consists of 30 items grouped into 8 dimensions: number of drugs, gait velocity, mood, activities of daily living, health status, nutrition, mental state and comorbidity/habits. It is an instrument that was developed and validated to assess the health status of elderly patients diagnosed with different hematological diseases, including MM. This scale may be a useful instrument in clinical practice as a support tool to predict tolerance to treatment in advanced age. The time required to complete the questionnaire is approximately 10-12 minutes. It will be provided only at the baseline visit for the patient to fill in before starting treatment. The patient must fill it in again each time he or she starts a new line. The questionnaire will be provided by the physician during the visit.
4 years
EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
This is a generic HRQoL questionnaire that contains a descriptive system and a visual analogue scale (VAS) for self-assessment of health status. The EQ-5D-5L's descriptive system contains a description of health state in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 possible responses. The respondent must mark the level of problems, within each dimension, that best describes his or her health state "today". It will be provided at each visit for the patient to fill in before starting treatment: at the baseline visit, approximately every 4 months in the first year (the visits must coincide with the patient's routine clinical practice visit) and after the first year every 6 months to progression. In case of progression and start of a second line of treatment, the questionnaire will start to be filled in with the same frequency initially described (baseline, every 4 months, etc.).
4 years
Quality of Life Questionnaire (QLQ-C30)
This is a cancer-specific questionnaire that consists of 30 items structured into 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status scale and, finally, 6 independent items (dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). Values from 1 to 4 are assigned depending on the patient's responses to the item. Only items 29 and 30 are evaluated with scoring from 1 to 7. Scores are standardised to obtain a score from 0 to 100, which determines the level of impact of the cancer on the patient for each scale. High scores on the overall health and functional status scales indicate a better QoL, while high scores on the symptoms scale would indicate a decrease in QoL since they indicate the presence of cancer-related symptoms.
4 years
Quality of Life Questionnaire - Multiple Myeloma Module 20 (QLQ-MY20)
This is a specific questionnaire used in combination with the QLQ-C30 generic questionnaire to evaluate quality of life in patients with MM. It consists of 20 items that address four specific domains - disease symptoms, side effects of treatment, future perspective and body image - and analyses various aspects of each dimension. Three of the four domains of the QLQ-MY20 are multi-item scales: Disease symptoms , side effects of treatment and future perspective (includes worry about death and health in the future and thinking about illness). The body image scale is a single-item scale that addresses physical attractiveness. The scores obtained are transformed linearly to a scale from 0 to 100. A high score in the disease symptoms and side effects domains represents a high level of symptoms or problems, while a high score in the future perspective and body image domains represents better outcomes.
4 years
Health care cost for Multiple Myeloma (MM) patients
MM-related direct healthcare resources and costs will be evaluated in each line MM treatment will be evaluated. The questionnaire will be provided by the physician during the visit. The resources used since the previous study visit will be collected at each visit.
4 years
Secondary Outcomes (6)
Time to progression (TTP)
4 years
Progression-free survival (PFS)
4 years
Overall survival (OS)
9 years
Overall response rate
4 years
Response duration
4 years
- +1 more secondary outcomes
Study Arms (1)
Patient with MM who are not candidates for ASCT
Patients with newly diagnosed MM who are not candidates for ASCT and who are going to start drug treatment for the study disease and patient who is capable of understanding and filling in the study questionnaires At least 450 patients will be enrolled in a 2-year period. Patients must meet all of the inclusion criteria and none of the exclusion criteria and must have previously granted their informed consent in writing.
Eligibility Criteria
At least 450 patients with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start drug treatment for the study disease will be enrolled.
You may qualify if:
- Patient ≥ 18 years of age.
- Patient with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start treatment for the study disease.
- Patient who is capable of understanding and filling in the study questionnaires.
- Patient who has granted his or her informed consent in writing.
You may not qualify if:
- Patient who is participating in the active phase of treatment of any clinical trial during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (65)
Hospital Punta de Europa
Algeciras, Andalusia, 11207, Spain
Hospital de Antequera
Antequera, Andalusia, 29200, Spain
Hospital Reina Sofía
Córdoba, Andalusia, 14004, Spain
Hospital Huercal Olvera
Huercal Olvera, Andalusia, 04600, Spain
Hospital General Jaén
Jaén, Andalusia, 23007, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Andalusia, 11407, Spain
Clinico Univ. Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Carlos Haya
Málaga, Andalusia, 29010, Spain
Hospital de Costa del Sol
Málaga, Andalusia, 29603, Spain
Hospital de Motril
Motril, Andalusia, 18600, Spain
Hospital Valle de los Pedroches Pozoblanco
Pozoblanco, Andalusia, 14400, Spain
Hospital Puerto Real
Puerto Real, Andalusia, 11510, Spain
Hospital de Macarena
Seville, Andalusia, 29200, Spain
Hospital Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital ICO Durán y Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital de Basurto
Bilbao, Basque Country, 48013, Spain
Hospital de Galadakao
Usansolo, Basque Country, 48960, Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009, Spain
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 38010, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, 09006, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital Clínico de Valladolid
Valladolid, Castille and León, 47003, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Catalonia, 08026, Spain
Hospital Vall Hebrón
Barcelona, Catalonia, 08035, Spain
Hospital General de Granollers
Granollers, Catalonia, 08402, Spain
Hospital Arnau Vilanova de Lleida
Lleida, Catalonia, 25198, Spain
Fundació Althaia
Manresa, Catalonia, 08243, Spain
Parc Taulí
Sabadell, Catalonia, 08208, Spain
Mutua Terrassa
Terrassa, Catalonia, 08221, Spain
Complejo Hospitalario Llerena-Zafra
Llerena, Extremadura, 06900, Spain
Hospital de Mérida
Mérida, Extremadura, 06800, Spain
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, 15006, Spain
Hospital Lucus Augustí
Lugo, Galicia, 27003, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005, Spain
Complexo Hospitalario de Pontevedra
Pontevedra, Galicia, 36071, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Galicia, 36312, Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, Islas Canaria, 38320, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Hospital de la Princesa
Madrid, Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703, Spain
Complejo Hospitalario de Navarra
Navarra, Navarre, 31008, Spain
Complejo Hospitalario Navarra
Pamplona, Navarre, 31008, Spain
Hospital de La Ribera
Alzira, Valencia, 46600, Spain
Hospital General Castellón
Castellon, Valencia, 12004, Spain
Hospital Arnau Vilanova Valencia
Valencia, Valencia, 46015, Spain
Hospital Doctor Peset
Valencia, Valencia, 46017, Spain
Hospital La Fe Valencia
Valencia, Valencia, 46026, Spain
Hospital La Ribera
Valencia, Valencia, 46600, Spain
Complejo Hospitalario de Ávila
Ávila, 05004, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Ramón y Cajal
Madrid, 28031, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario La Fe
Valencia, 46026, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Related Publications (1)
Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
PMID: 33218965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giselle Lostaunau, Senior Medical Advisor MM
Celgene
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 27, 2016
Study Start
December 25, 2016
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
November 22, 2022
Record last verified: 2022-11