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Multiple MyelomaNCT03188536

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

An observational study of Multiple Myeloma, run by Takeda at 30 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
282 participants
Where
30 sitesSpain
Study dates
26 Jul 2017to 30 Jan 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Participants who do not agree to participate in the study or who do not give written informed consent.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Spain30 sites

  • Hospital Clinico de Barcelona

    Barcelona, Catalonia, 8036

  • Hospital de Burgos

    Burgos, Castille and León, 9006

  • H Universitario Puerta del Mar

    Cadiz, Andalusia, 11009

  • H de Donosti

    Donostia / San Sebastian, Basque Country, 20014

  • H Universitario de Cabuenes

    Gijón, Principality of Asturias, 33394

  • Hospital Doctor Trueta ICO Girona

    Girona, Catalonia, 17007

  • H Virgen de las Nieves

    Granada, Andalusia, 18014

  • H U de Guadalajara

    Guadalajara, Castille-La Mancha, 19002

  • Hospital Juan Ramon Jimenez

    Huelva, Andalusia, 21005

  • H Jerez

    Jerez de la Frontera, Andalusia, 11408

  • ICO Bellvitge

    L'Hospitalet de Llobregat, Catalonia, 8908

  • Hospital de Leon

    León, Castille and León, 24001

  • Hospital Lucus Agusti

    Lugo, Galicia, 27003

  • H Infanta Leonor

    Madrid, 28031

  • H 12 de Octubre

    Madrid, 28041

  • Hospital Costa del Sol

    Marbella, Andalusia, 29603

  • H Son Espases

    Palma, Balearic Islands, 7120

  • Hospital Son Llatzer

    Palma, Balearic Islands, 7198

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Salamanca

    Salamanca, Castille and León, 37007

  • H U Canarias

    San Cristóbal de La Laguna, Canary Islands, 38320

  • H Marques de Valdecilla

    Santander, Cantabria, 39008

  • H Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706

  • Complejo Asistencial de Segovia

    Segovia, Castille and León, 40002

  • H. Nuestra Senora de Valme

    Seville, Andalusia, 41014

  • H Universitari de Tarragona Joan XXIII

    Tarragona, Catalonia, 43005

  • Complejo Hospitalario Toledo

    Toledo, Castille-La Mancha, 45071

  • H Clinico de Valencia

    Valencia, 46010

  • Hospital de Txagorritxu

    Vitoria-Gasteiz, Basque Country, 1009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
No Intervention
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    As it was an observational study, no intervention was administered in this study.

Study groups in NCT03188536
Study groupRoleWhat they receive
Multiple Myeloma (MM) ParticipantsAdult participants with a diagnosis of MM who received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 1

  2. 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,β2-Microglobulin<3.5mg/L and albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-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).

    Measured: Day 1

  3. 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.

    Measured: Day 1

Secondary outcomes (6)

  1. 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,β2-Microglobulin<3.5mg/L,albumin≥3.5g/dL,II:not stage I or III,III:high risk,β2-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.

    Measured: Day 1

  2. Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. 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.

    Measured: Day 1

  5. 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.

    Measured: Day 1

  6. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2017
  2. Study start26 Jul 2017
  3. Primary completion15 Nov 2018
  4. Study completion30 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188536
Sponsor's protocol ID
RRMM-5012
Other IDs
TAK-MMR-2017-01
Status last verified
Sep 2020
First submitted
12 Jun 2017
Last updated
12 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Publications

  • Dachs LR, Gaisan CM, Bustamante G, Lopez SG, Garcia EG, Persona EP, Gonzalez-Calle V, Auzmendi MS, Perez JMA, Gonzalez Montes Y, Rios Tamayo R, de Miguel Llorente D, Bernal LP, Mayol AS, Caro CC, Grande M, Fernandez-Nistal A, Naves A, Miguel EMOS. Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study. Leuk Lymphoma. 2023 Nov-Dec;64(11):1847-1856. doi: 10.1080/10428194.2023.2240922. Epub 2023 Aug 4.

    PubMed 37539698

  • Ocio EM, Montes-Gaisan C, Bustamante G, Garzon S, Gonzalez E, Perez-Persona E, Gonzalez-Calle V, Sirvent M, Arguinano JM, Gonzalez Y, Rios R, de Miguel D, Grande M, Fernandez-Nistal A, Naves A, Rosinol L. Real-World Health Care Services Utilization Associated With the Management of Patients With Relapsed and Refractory Multiple Myeloma in Spain: The CharisMMa Study. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e341-e347. doi: 10.1016/j.clml.2023.07.006. Epub 2023 Jul 15.

    PubMed 37517875

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Takeda at 30 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03188536, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.

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