Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946333
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease
Multiple Myeloma

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 25, 2016
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : October 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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.



Primary Outcome Measures :
  1. Health-related quality of life (HRQoL) [ Time Frame: 4 years ]
    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.

  2. EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: 4 years ]
    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.).

  3. Quality of Life Questionnaire (QLQ-C30) [ Time Frame: 4 years ]
    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. Quality of Life Questionnaire — Multiple Myeloma Module 20 (QLQ-MY20) [ Time Frame: 4 years ]
    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.

  5. Health care cost for Multiple Myeloma (MM) patients [ Time Frame: 4 years ]
    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.


Secondary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: 4 years ]
    Time that elapses from the start of a treatment up to disease progression.

  2. Progression-free survival (PFS) [ Time Frame: 4 years ]
    Time that elapses from the start of a treatment to disease progression or death, whichever occurs first.

  3. Overall survival (OS) [ Time Frame: 9 years ]
    Time that elapses from the diagnosis of the disease up to the death of the patient for any reason.

  4. Overall response rate [ Time Frame: 4 years ]
    Response measured through the IMWG criteria: Stringent complete response; complete response (CR); very good partial response; partial response (PR); stable disease (SD); progression (P)

  5. Response duration [ Time Frame: 4 years ]
    For each line of treatment for multiple myeloma (MM) during the study period

  6. Treatment-free interval [TFI] [ Time Frame: 4 years ]
    Time between relapse and start of a new treatment (second/third lines)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946333


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Hide Study Locations
Locations
Layout table for location information
Spain
Hospital Punta de Europa Not yet recruiting
Algeciras, Andalusia, Spain, 11207
Hospital de Antequera Active, not recruiting
Antequera, Andalusia, Spain, 29200
Hospital Reina Sofía Active, not recruiting
Córdoba, Andalusia, Spain, 14004
Hospital Huercal Olvera Not yet recruiting
Huercal Olvera, Andalusia, Spain, 04600
Hospital General Jaén Not yet recruiting
Jaén, Andalusia, Spain, 23007
Hospital Jerez de la Frontera Recruiting
Jerez de la Frontera, Andalusia, Spain, 11407
Hospital de Motril Recruiting
Motril, Andalusia, Spain, 18600
Clinico Univ. Virgen de la Victoria Recruiting
Málaga, Andalusia, Spain, 29010
Hospital Carlos Haya Recruiting
Málaga, Andalusia, Spain, 29010
Hospital de Costa del Sol Recruiting
Málaga, Andalusia, Spain, 29603
Hospital Valle de los Pedroches Pozoblanco Recruiting
Pozoblanco, Andalusia, Spain, 14400
Hospital Puerto Real Recruiting
Puerto Real, Andalusia, Spain, 11510
Hospital de Macarena Active, not recruiting
Sevilla, Andalusia, Spain, 29200
Hospital Miguel Servet Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Hospital ICO Durán y Reynals Not yet recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08908
ICO Duran i Reynals Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08908
Hospital Universitario Dr. Negrín Recruiting
Las Palmas de Gran Canaria, Canarias, Spain, 35010
Hospital de Guadalajara Active, not recruiting
Guadalajara, Castilla La Mancha, Spain, 19002
Hospital Universitario de Burgos Active, not recruiting
Burgos, Castilla Y León, Spain, 09006
Hospital Clínico Universitario de Salamanca Active, not recruiting
Salamanca, Castilla Y León, Spain, 37007
Hospital Clínico de Valladolid Recruiting
Valladolid, Castilla Y León, Spain, 47003
Hospital del Mar Recruiting
Barcelona, Cataluña, Spain, 08003
Hospital Santa Creu i Sant Pau Active, not recruiting
Barcelona, Cataluña, Spain, 08026
Hospital Vall Hebrón Recruiting
Barcelona, Cataluña, Spain, 08035
Hospital General de Granollers Recruiting
Granollers, Cataluña, Spain, 08402
Hospital Arnau Vilanova de Lleida Recruiting
Lleida, Cataluña, Spain, 25198
Fundació Althaia Recruiting
Manresa, Cataluña, Spain, 08243
Parc Taulí Recruiting
Sabadell, Cataluña, Spain, 08208
Mutua Terrassa Recruiting
Terrassa, Cataluña, Spain, 08221
Hospital Universitario de Getafe Not yet recruiting
Getafe, Comunidad De Madrid, Spain, 28905
Hospital de la Princesa Recruiting
Madrid, Comunidad De Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Comunidad De Madrid, Spain, 28007
Hospital Clínico San Carlos Recruiting
Madrid, Comunidad De Madrid, Spain, 28040
Hospital Universitario Fundación Jiménez Díaz Recruiting
Madrid, Comunidad De Madrid, Spain, 28040
Hospital 12 de Octubre Active, not recruiting
Madrid, Comunidad De Madrid, Spain, 28041
Hospital General Castellón Active, not recruiting
Castellón de la Plana, Comunidad Valenciana, Spain, 12004
Hospital Arnau Vilanova Valencia Recruiting
Valencia, Comunidad Valenciana, Spain, 46015
Hospital Doctor Peset Recruiting
Valencia, Comunidad Valenciana, Spain, 46017
Hospital La Fe Valencia Recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Hospital La Ribera Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46600
Hospital Punta de Europa Active, not recruiting
Algeciras, Cádiz, Spain, 11207
Complejo Hospitalario Llerena-Zafra Recruiting
Llerena, Extremadura, Spain, 06900
Hospital de Mérida Active, not recruiting
Mérida, Extremadura, Spain, 06800
Complexo Hospitalario Universitario de A Coruña Not yet recruiting
A Coruña, Galicia, Spain, 15006
Hospital Lucus Augustí Recruiting
Lugo, Galicia, Spain, 27003
Complexo Hospitalario Universitario de Ourense Recruiting
Ourense, Galicia, Spain, 32005
Complexo Hospitalario de Pontevedra Recruiting
Pontevedra, Galicia, Spain, 36071
Complexo Hospitalario Universitario de Vigo Recruiting
Vigo, Galicia, Spain, 36312
Hospital Son Espases Recruiting
Palma de Mallorca, Islas Baleares, Spain, 07120
Hospital Son Llàtzer Recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Dr. Negrín Not yet recruiting
Las Palmas de Gran Canaria, Islas Canarias, Spain, 38010
Hospital Universitario Nuestra Señora de Candelaria Not yet recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
Hospital Universitario Canarias Recruiting
Santa Cruz de Tenerife, Islas Canaria, Spain, 38320
Hospital Quirón Recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Hospital Infanta Sofía Recruiting
San Sebastián de los Reyes, Madrid, Spain, 28703
Complejo Hospitalario Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Hospital de Basurto Recruiting
Bilbao, País Vasco, Spain, 48013
Hospital de Galadakao Recruiting
Usansolo, País Vasco, Spain, 48960
Hospital de Txagorritxu Recruiting
Vitoria-Gasteiz, País Vasco, Spain, 01009
Hospital de La Ribera Recruiting
Alzira, Valencia, Spain, 46600
Hospital Infanta Leonor Recruiting
Madrid, Spain, 28031
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28031
Hospital La Paz Recruiting
Madrid, Spain, 28046
Complejo Hospitalario de Navarra Recruiting
Navarra, Spain, 31008
Hospital Virgen de la Salud Not yet recruiting
Toledo, Spain, 45071
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46026
Hospital Miguel Servet Recruiting
Zaragoza, Spain, 50009
Complejo Hospitalario de Ávila Recruiting
Ávila, Spain, 05004
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Marta Duran, RML Advocacy MM Celgene Corporation

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02946333     History of Changes
Other Study ID Numbers: CEL-MIE-2016-01
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Celgene:
Multiple Myeloma
autologous stem cell transplant (ASCT)
QoLMMBuS
healthcare costs
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases