ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03188536
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment
Multiple Myeloma Other: No Intervention

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.


Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
Multiple Myeloma (MM) Participants
Adult participants with a diagnosis of MM who have received at least one previous treatment line (standard care of treatment) 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. No intervention is administered in this study.
Other: No Intervention
No Intervention




Primary Outcome Measures :
  1. Percentage of MM Participants Categorized by Sociodemographic Variables [ Time Frame: Day 1 ]
    Sociodemographic variables include age (in years), sex (male or female), body mass index (BMI), area of residence (rural or urban), educational level (illiterate, no studies (can only read/write), primary studies, secondary studies, or university studies), cohabitation (lives alone, lives with the family, lives alone with help from a caregiver, daily, 2-3 times/week, permanent or night-time), degree of dependence (independent, dependent grade I - requires help to perform activities of daily living (ADL) at least once a day, dependent grade II - needs help to perform ADLs 2 or 3 times a day or dependent grade III - needs help to perform ADLs several times a day), working situation (unemployed, in active employment, full time, part time, temporarily/ permanently disabled, retired, student or other), need for financial assistance (yes/no), healthy habits (high/moderate physical activity or inactive, smoking habit (yes/no), alcohol use (yes/no).

  2. Percentage of MM Participants Categorized by Clinical Variables on Diagnosis and During Previous Relapses [ Time Frame: Day 1 ]
    Clinical variables include age (at diagnosis), MM type (heavy/light chain/ Bence-Jones protein), international staging system (ISS) disease stage (stage I-low risk, β2-Microglobulin <3.5 mg/L and albumin ≥3.5 g/dL, stage II-not ISS stage I or III, stage III-high risk, β2-Microglobulin ≥5.5 mg/L), calcium, renal insufficiency, anemia or bone lesions (CRAB) signs (serum calcium >0.25 mmol/L upper limit of normal, renal failure-creatinine clearance <40 mL/min/ serum creatinine >117 μmol/L, anemia:reduction of hemoglobin (Hb) >2 g/dL below lower limit of normal or Hb <10 g/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 risk:trisomies, t[11;14];t[6;14], intermediate risk:t[4;14],g[1q], high risk: d[17p],t[14;16],t[14;20]), previous relapses (before the latest), received stem cell transplant, eastern cooperative oncology group (ECOG:0-5).

  3. Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode [ Time Frame: Day 1 ]
    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, lactate dehydrogenase levels, paraprotein levels, free light chain levels, concomitant diseases, diabetes, neuropathy, chronic obstructive pulmonary disease, cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders, cytogenetic abnormalities, risk according to cytogenetic profile at relapse, treatment started after latest symptomatic relapse and/or refractory episode, concomitant diseases at time of latest symptomatic relapse and/or refractory (R/R) episode.


Secondary Outcome Measures :
  1. Percentage of MM Participants with Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode [ Time Frame: Day 1 ]
    Treatment selection includes treatment line and therapeutic group.

  2. Number of new Relevant Variables that are not Currently Collected in Clinical Records and that Could Influence in the Disease Management at Relapse [ Time Frame: 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 (EORTC QLQ-C30) [ Time Frame: Day 7 ]
    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. 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. The questionnaire is completed with assessment over the previous 7 days.

  4. HRQOL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score [ Time Frame: Day 7 ]
    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). Scores are averaged, and transformed scores ranging from 0 to 100. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology. The questionnaire is completed with assessment over the previous 7 days.

  5. HRQOL based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) [ Time Frame: Day 7 ]
    The Spanish version of 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). Scores are averaged, and transformed scores ranging from 0 to 100. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology. The questionnaire is completed with assessment over the previous 7 days.

  6. Health Care Resource Utilization (HU): Number of Medical Encounters [ Time Frame: Day 1 ]
    Healthcare resources used during medical encounters include transport use, hospital visits, intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted, visits to specialists, test use, accompanying person in active employment.



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.


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
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.
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.


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): NCT03188536


Contacts
Contact: Takeda Study Registration Call Center +1-844-617-6468 GlobalOncologyMedinfo@takeda.com

Locations
Spain
H Universitario Puerta del Mar Not yet recruiting
Cadiz, Andalucia, Spain, 11009
H Virgen de las Nieves Not yet recruiting
Granada, Andalucia, Spain, 18014
Hospital Juan Ramon Jimenez Not yet recruiting
Huelva, Andalucia, Spain, 21005
H Jerez Not yet recruiting
Jerez de la Frontera, Andalucia, Spain, 11408
Hospital Costa del Sol Not yet recruiting
Marbella, Andalucia, Spain, 29603
H. Nuestra Senora de Valme Recruiting
Sevilla, Andalucia, Spain, 41014
Hospital Clinico Universitario Lozano Blesa Not yet recruiting
Zaragoza, Aragon, Spain, 50009
H Universitario de Cabuenes Not yet recruiting
Gijon, Asturias, Spain, 33394
H U Canarias Recruiting
San Cristobal de La Laguna, Canarias, Spain, 38320
H Marques de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
H U de Guadalajara Not yet recruiting
Guadalajara, Castilla La Mancha, Spain, 19002
Complejo Hospitalario Toledo Not yet recruiting
Toledo, Castilla La Mancha, Spain, 45071
Hospital de Burgos Not yet recruiting
Burgos, Castilla Y Leon, Spain, 9006
Hospital de Leon Recruiting
Leon, Castilla Y Leon, Spain, 24001
Hospital de Salamanca Recruiting
Salamanca, Castilla Y Leon, Spain, 37007
Complejo Asistencial de Segovia Not yet recruiting
Segovia, Castilla Y Leon, Spain, 40002
Hospital Clinico de Barcelona Not yet recruiting
Barcelona, Cataluna, Spain, 8036
Hospital Doctor Trueta ICO Girona Not yet recruiting
Girona, Cataluna, Spain, 17007
ICO Bellvitge Not yet recruiting
Hospitalet de Llobregat, Cataluna, Spain, 8908
H Universitari de Tarragona Joan XXIII Not yet recruiting
Tarragona, Cataluna, Spain, 43005
Hospital Lucus Agusti Not yet recruiting
Lugo, Galicia, Spain, 27003
H Clinico Universitario de Santiago Not yet recruiting
Santiago de Compostela, Galicia, Spain, 15706
H Son Espases Not yet recruiting
Palma, Islas Baleares, Spain, 7120
Hospital Son Llatzer Not yet recruiting
Palma, Islas Baleares, Spain, 7198
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
H de Donosti Not yet recruiting
Donostia, Pais Vasco, Spain, 20014
Hospital de Txagorritxu Not yet recruiting
Vitoria-Gasteiz, Pais Vasco, Spain, 1009
H Infanta Leonor Not yet recruiting
Madrid, Spain, 28031
H 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
H Clinico de Valencia Not yet recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Monitor Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03188536     History of Changes
Other Study ID Numbers: RRMM-5012
TAK-MMR-2017-01 ( Registry Identifier: Spanish health authority )
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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