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

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ClinicalTrials.gov Identifier: NCT03188536
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date June 12, 2017
First Posted Date June 15, 2017
Last Update Posted Date February 20, 2019
Actual Study Start Date July 26, 2017
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2017)
  • 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).
  • 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).
  • 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.
Original Primary Outcome Measures
 (submitted: June 13, 2017)
  • 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).
  • 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), ISS (international staging system) 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), CRAB (calcium, renal insufficiency, anemia or bone lesions) 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).
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2017)
  • 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.
  • 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 ]
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
Official Title Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Spain
Brief Summary The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Multiple Myeloma
Intervention Other: No Intervention
No Intervention
Study Groups/Cohorts 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.
Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2018)
280
Original Estimated Enrollment
 (submitted: June 13, 2017)
350
Actual Study Completion Date January 30, 2019
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03188536
Other Study ID Numbers RRMM-5012
TAK-MMR-2017-01 ( Registry Identifier: Spanish health authority )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Clinical Science Takeda
PRS Account Takeda
Verification Date February 2019