NCT03188536

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

Completed Results posted Last updated 12 October 2020

What this trial tests

trial testing No Intervention in Multiple Myeloma in 282 participants. Completed in 30 January 2019.

Timeline

26 July 2017

Primary endpoint
15 November 2018

30 January 2019

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	282
Start date	26 July 2017
Primary completion	15 November 2018
Estimated completion	30 January 2019
Sites	30 locations across Spain

Drugs / interventions tested

• No Intervention

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis Primary · Day 1

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 perfo

Age, Adults (27-90 years)

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Sex, Male

Group	Value	95% CI
Multiple Myeloma (MM) Participants	53.3

Sex, Female

Group	Value	95% CI
Multiple Myeloma (MM) Participants	46.7

BMI, 15 to 52 kg/m^2

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Area of Residence, Rural

Group	Value	95% CI
Multiple Myeloma (MM) Participants	24.3

Area of Residence, Urban

Group	Value	95% CI
Multiple Myeloma (MM) Participants	75.7

Educational level, Illiteracy

Group	Value	95% CI
Multiple Myeloma (MM) Participants	0.7

Educational level, No Studies (just read/write)

Group	Value	95% CI
Multiple Myeloma (MM) Participants	10.4

Percentage of MM Participants Categorized by Clinical Variables at Diagnosis Primary · Day 1

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

Age, Adults (27-90 years)

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

MM Type, Heavy chain, IgA

Group	Value	95% CI
Multiple Myeloma (MM) Participants	24.1

MM Type, Heavy chain, IgD

Group	Value	95% CI
Multiple Myeloma (MM) Participants	1.9

MM Type, Heavy chain, IgG

Group	Value	95% CI
Multiple Myeloma (MM) Participants	56.8

MM Type, Heavy chain, IgM

Group	Value	95% CI
Multiple Myeloma (MM) Participants	0.8

MM Type, Heavy chain, No Heavy Chain

Group	Value	95% CI
Multiple Myeloma (MM) Participants	16.5

MM Type, Light Chain, No Light Chain

Group	Value	95% CI
Multiple Myeloma (MM) Participants	3.3

MM Type, Light Chain, Kappa

Group	Value	95% CI
Multiple Myeloma (MM) Participants	59.8

Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode Primary · 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, 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\

Relapse Within 6 Months of Last Relapse

Group	Value	95% CI
Multiple Myeloma (MM) Participants	61.6

ISS Disease Stage I

Group	Value	95% CI
Multiple Myeloma (MM) Participants	37.4

ISS Disease Stage II

Group	Value	95% CI
Multiple Myeloma (MM) Participants	35.5

ISS Disease Stage III

Group	Value	95% CI
Multiple Myeloma (MM) Participants	27.0

CRAB Signs, None

Group	Value	95% CI
Multiple Myeloma (MM) Participants	25.7

CRAB Signs, Some-Increase in blood calcium levels

Group	Value	95% CI
Multiple Myeloma (MM) Participants	9.3

CRAB Signs, Some-Renal Failure

Group	Value	95% CI
Multiple Myeloma (MM) Participants	20.5

CRAB Signs, Some-Anemia

Group	Value	95% CI
Multiple Myeloma (MM) Participants	43.9

Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode Secondary · Day 1

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

Age, 38-85 years, IMiDs

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Age, 43-76 years, PI + IMiDs

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Age, 47-84 years, PI

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Age, 39-80 years, mAb

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Age, 53-90 years, Other

Group	Value	95% CI
Multiple Myeloma (MM) Participants	100

Sex, Male, IMiDs

Group	Value	95% CI
Multiple Myeloma (MM) Participants	49.4

Sex, Female, IMiDs

Group	Value	95% CI
Multiple Myeloma (MM) Participants	50.6

Sex, Male, PI + IMiDs

Group	Value	95% CI
Multiple Myeloma (MM) Participants	61.2

Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 Secondary · Day 1

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

Group	Value	95% CI
Multiple Myeloma (MM) Participants	53.5	± 23.9

HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score Secondary · Day 1

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.

Future perspective

Group	Value	95% CI
Multiple Myeloma (MM) Participants	58.4	± 27.7

Body image

Group	Value	95% CI
Multiple Myeloma (MM) Participants	72.9	± 34.4

Symptoms of the disease

Group	Value	95% CI
Multiple Myeloma (MM) Participants	30.7	± 23.2

Adverse effects of the treatment

Group	Value	95% CI
Multiple Myeloma (MM) Participants	25.4	± 17.2

HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Secondary · Day 1

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 symp

Future perspective, Factors I-II

Group	Value	95% CI
Multiple Myeloma (MM) Participants	60.3	± 28.2

Future perspective, Factors III

Group	Value	95% CI
Multiple Myeloma (MM) Participants	53.9	± 24.9

Body image, Factors I-II

Group	Value	95% CI
Multiple Myeloma (MM) Participants	73.9	± 35.5

Body image, Factors III

Group	Value	95% CI
Multiple Myeloma (MM) Participants	73.0	± 32.7

Symptoms of the disease, Factors I-II

Group	Value	95% CI
Multiple Myeloma (MM) Participants	31.9	± 23.6

Symptoms of the disease, Factors III

Group	Value	95% CI
Multiple Myeloma (MM) Participants	27.3	± 22.1

Adverse effects of the treatment, Factors I-II

Group	Value	95% CI
Multiple Myeloma (MM) Participants	24.3	± 16.9

Adverse effects of the treatment, Factors III

Group	Value	95% CI
Multiple Myeloma (MM) Participants	29.0	± 17.5

Percentage of Participants With Health Care Resource Utilization (HU) Secondary · Day 1

Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.

Admitted at some healthcare service

Group	Value	95% CI
Multiple Myeloma (MM) Participants	56.2

Admitted to Hospital

Group	Value	95% CI
Multiple Myeloma (MM) Participants	59.4

Used ambulance to attend to the hospital

Group	Value	95% CI
Multiple Myeloma (MM) Participants	7.0

Used their own transport

Group	Value	95% CI
Multiple Myeloma (MM) Participants	67.8

Consultation with the primary care physician

Group	Value	95% CI
Multiple Myeloma (MM) Participants	21.7

Consultation with the oncologist

Group	Value	95% CI
Multiple Myeloma (MM) Participants	2.5

Consultation with the psychologist

Group	Value	95% CI
Multiple Myeloma (MM) Participants	3.6

Attended psychologist

Group	Value	95% CI
Multiple Myeloma (MM) Participants	60

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Updates from the 2019 American Society of Clinical Oncology and European Hematology Association annual meetings: a Canadian perspective on high-risk cytogenetics in multiple myeloma.
   LeBlanc R, Song K, White D, Christofides A, et al · · 2019 · cited 3× · PMID 31548829 · DOI 10.3747/co.26.5565
2. 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.
   Dachs LR, Gaisán CM, Bustamante G, López SG, et al · · 2023 · cited 1× · PMID 37539698 · DOI 10.1080/10428194.2023.2240922
3. Real-World Health Care Services Utilization Associated With the Management of Patients With Relapsed and Refractory Multiple Myeloma in Spain: The CharisMMa Study.
   Ocio EM, Montes-Gaisán C, Bustamante G, Garzón S, et al · · 2023 · cited 1× · PMID 37517875 · DOI 10.1016/j.clml.2023.07.006
4. LX Congreso Nacional de la Sociedad Española de Hematología y Hemoterapia Granada, España, 11-13 de octubre, 2018
   · 2018