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

Multiple Myeloma Clinical Trial

— QoLMMBuS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946333
• Other study ID #: CEL-MIE-2016-01
• Status: Completed
• Start date: December 25, 2016
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:

1. Recruitment period: data collection at the baseline visit, every 4 months +/- 15 days in the first year (month 4, 8 and 12) and every 6 months +/- 1 month in the second year (month 18 and 24).

2. Follow-up period: (study will end at 4 years following enrolment of the first patient)

• From month 24 until up to 4 years from enrolment of the first patient, follow-ups will be performed with semi-annual data collections coinciding with the patient's routine clinical practice visits.

• In case of progression, suspension or unexpected termination of treatment (for example due to toxicity), or death, a data collection coinciding with the visit in which any of the cases presented occurs will be performed.

• If a new line of treatment is started, the follow-up model will be started with the same frequency of follow-ups described in point 1 above (month 4, 8, 12, 18 and 24 and semi-annually according to routine clinical practice until up to 4 years from enrolment of the first patient in the study).

3. Observation period: Following this 4-year period, an additional 5-year follow-up will be performed only to evaluate the onset of second primary malignant neoplasms. This follow-up during the 5-year observational period will be performed semi-annually (± 1 month) according to routine clinical practice at each site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient who is participating in the active phase of treatment of any clinical trial during the study period.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña	Galicia
Spain	Hospital Punta de Europa	Algeciras	Andalusia
Spain	Hospital de La Ribera	Alzira	Valencia
Spain	Hospital de Antequera	Antequera	Andalusia
Spain	Complejo Hospitalario de Ávila	Ávila
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital Vall Hebrón	Barcelona	Cataluña
Spain	Hospital de Basurto	Bilbao	País Vasco
Spain	Hospital Universitario de Burgos	Burgos	Castilla Y León
Spain	Hospital General Castellón	Castellón de la Plana	Comunidad Valenciana
Spain	Hospital Reina Sofía	Córdoba	Andalusia
Spain	Hospital Universitario de Getafe	Getafe	Comunidad De Madrid
Spain	Hospital General de Granollers	Granollers	Cataluña
Spain	Hospital ICO Durán y Reynals	Hospitalet de Llobregat	Barcelona
Spain	ICO Duran i Reynals	Hospitalet de Llobregat	Barcelona
Spain	Hospital Huercal Olvera	Huercal Olvera	Andalusia
Spain	Hospital General Jaén	Jaén	Andalusia
Spain	Hospital Jerez de la Frontera	Jerez de la Frontera	Andalusia
Spain	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Islas Canarias
Spain	Hospital Universitario Dr. Negrín	Las Palmas de Gran Canaria	Canarias
Spain	Hospital Arnau Vilanova de Lleida	Lleida	Cataluña
Spain	Complejo Hospitalario Llerena-Zafra	Llerena	Extremadura
Spain	Hospital Lucus Augustí	Lugo	Galicia
Spain	Hospital 12 de Octubre	Madrid	Comunidad De Madrid
Spain	Hospital Clínico San Carlos	Madrid	Comunidad De Madrid
Spain	Hospital de la Princesa	Madrid	Comunidad De Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid	Comunidad De Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid	Comunidad De Madrid
Spain	Clinico Univ. Virgen de la Victoria	Málaga	Andalusia
Spain	Hospital Carlos Haya	Málaga	Andalusia
Spain	Hospital de Costa del Sol	Málaga	Andalusia
Spain	Fundació Althaia	Manresa	Cataluña
Spain	Hospital de Mérida	Mérida	Extremadura
Spain	Hospital de Motril	Motril	Andalusia
Spain	Complejo Hospitalario de Navarra	Navarra
Spain	Complexo Hospitalario Universitario de Ourense	Ourense	Galicia
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital Son Llàtzer	Palma de Mallorca	Islas Baleares
Spain	Complejo Hospitalario Navarra	Pamplona	Navarra
Spain	Complexo Hospitalario de Pontevedra	Pontevedra	Galicia
Spain	Hospital Valle de los Pedroches Pozoblanco	Pozoblanco	Andalusia
Spain	Hospital Quirón	Pozuelo de Alarcón	Madrid
Spain	Hospital Puerto Real	Puerto Real	Andalusia
Spain	Parc Taulí	Sabadell	Cataluña
Spain	Hospital Clínico Universitario de Salamanca	Salamanca	Castilla Y León
Spain	Hospital Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	Hospital Universitario Canarias	Santa Cruz de Tenerife	Islas Canaria
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital de Macarena	Sevilla	Andalusia
Spain	Mutua Terrassa	Terrassa	Cataluña
Spain	Hospital de Galadakao	Usansolo	País Vasco
Spain	Hospital Arnau Vilanova Valencia	Valencia	Comunidad Valenciana
Spain	Hospital Doctor Peset	Valencia	Comunidad Valenciana
Spain	Hospital La Fe Valencia	Valencia	Comunidad Valenciana
Spain	Hospital La Ribera	Valencia	Comunidad Valenciana
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid	Castilla Y León
Spain	Complexo Hospitalario Universitario de Vigo	Vigo	Galicia
Spain	Hospital de Txagorritxu	Vitoria-Gasteiz	País Vasco
Spain	Hospital Miguel Servet	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Time to progression (TTP)	Time that elapses from the start of a treatment up to disease progression.	4 years
Secondary	Progression-free survival (PFS)	Time that elapses from the start of a treatment to disease progression or death, whichever occurs first.	4 years
Secondary	Overall survival (OS)	Time that elapses from the diagnosis of the disease up to the death of the patient for any reason.	9 years
Secondary	Overall response rate	Response measured through the IMWG criteria: Stringent complete response; complete response (CR); very good partial response; partial response (PR); stable disease (SD); progression (P)	4 years
Secondary	Response duration	For each line of treatment for multiple myeloma (MM) during the study period	4 years
Secondary	Treatment-free interval [TFI]	Time between relapse and start of a new treatment (second/third lines)	4 years