Clinical and Sociodemographic Characterization of Multiple Myeloma Participants 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

Results First Posted : October 12, 2020

Last Update Posted : October 12, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Takeda

Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Retrospective
Condition	Multiple Myeloma
Intervention	Other: No Intervention
Enrollment	282

Participant Flow

Recruitment Details	Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019.
Pre-assignment Details	Participants with a diagnosis of multiple myeloma with symptomatic relapse and/or refractory disease were observed to collect the retrospective data on Day 1.


Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description	Adult participants with a diagnosis...
Arm/Group Description	Adult participants with a diagnosis of MM 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.
Period Title: Overall Study
Started	282
Completed	276
Not Completed	6
Reason Not Completed
No relapse/refractoriness(last 6 months)	5
Not participated/met inclusion criteria	1

Baseline Characteristics

Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description		Adult participants with a diagnosis...
Arm/Group Description		Adult participants with a diagnosis of MM 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.
Overall Number of Baseline Participants		276
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All participants eligible for analyses were included.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	276 participants
		67.4 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	276 participants
	Female	129 46.7%
	Male	147 53.3%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
Spain	Number Analyzed	276 participants
Spain		276 100.0%
Body Mass Index (BMI) ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	276 participants
		27.5 (5.1)
		[1] Measure Description: BMI=Weight (kg)/Height(m)^2.

Outcome Measures

1.Primary Outcome


Title	Percentage of MM Participants Categorized by Sociodemographic Variables at Diagnosis
Description	Sociodemographic variables included age(in years), sex(male or female)...
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Percentages were rounded off.


Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description:		Adult participants with a diagnosis...
Arm/Group Description:		Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed		276
Measure Type: Number Unit of Measure: percentage of participants
Age, Adults (27-90 years)	Number Analyzed	276 participants
Age, Adults (27-90 years)		100
Sex, Male	Number Analyzed	276 participants
Sex, Male		53.3
Sex, Female	Number Analyzed	276 participants
Sex, Female		46.7
BMI, 15 to 52 kg/m^2	Number Analyzed	276 participants
BMI, 15 to 52 kg/m^2		100
Area of Residence, Rural	Number Analyzed	276 participants
Area of Residence, Rural		24.3
Area of Residence, Urban	Number Analyzed	276 participants
Area of Residence, Urban		75.7
Educational level, Illiteracy	Number Analyzed	270 participants
Educational level, Illiteracy		0.7
Educational level, No Studies (just read/write)	Number Analyzed	270 participants
Educational level, No Studies (just read/write)		10.4
Educational level, Primary studies	Number Analyzed	270 participants
Educational level, Primary studies		43.3
Educational level, Secondary studies	Number Analyzed	270 participants
Educational level, Secondary studies		34.1
Educational level, Higher studies	Number Analyzed	270 participants
Educational level, Higher studies		11.5
Work Status, Unemployed	Number Analyzed	275 participants
Work Status, Unemployed		5.5
Work Status, Active	Number Analyzed	275 participants
Work Status, Active		5.1
Work Status, Temporary/permanent disability	Number Analyzed	275 participants
Work Status, Temporary/permanent disability		20.0
Work Status, Retired	Number Analyzed	275 participants
Work Status, Retired		65.1
Work Status, Other	Number Analyzed	275 participants
Work Status, Other		4.4
Cohabitation status, Living Alone	Number Analyzed	274 participants
Cohabitation status, Living Alone		12.4
Cohabitation status, Living with Relatives	Number Analyzed	274 participants
Cohabitation status, Living with Relatives		85.8
Cohabitation, Living Alone with Assistance	Number Analyzed	274 participants
Cohabitation, Living Alone with Assistance		1.8
Need of Financial Support, No	Number Analyzed	274 participants
Need of Financial Support, No		93.8
Level of Dependence, Independent	Number Analyzed	275 participants
Level of Dependence, Independent		71.3
Level of Dependence, Grade I	Number Analyzed	275 participants
Level of Dependence, Grade I		14.5
Level of Dependence, Grade II	Number Analyzed	275 participants
Level of Dependence, Grade II		12.7
Level of Dependence, Grade III	Number Analyzed	275 participants
Level of Dependence, Grade III		1.5
Physical Activity, High	Number Analyzed	275 participants
Physical Activity, High		1.8
Physical Activity, Moderate	Number Analyzed	275 participants
Physical Activity, Moderate		45.8
Physical Activity, Inactive	Number Analyzed	275 participants
Physical Activity, Inactive		52.4
Current smoking habit, Yes	Number Analyzed	276 participants
Current smoking habit, Yes		3.6
Current smoking habit, No	Number Analyzed	276 participants
Current smoking habit, No		96.4
Alcohol Use, Yes	Number Analyzed	276 participants
Alcohol Use, Yes		6.5
Alcohol Use, No	Number Analyzed	276 participants
Alcohol Use, No		93.5

2.Primary Outcome


Title	Percentage of MM Participants Categorized by Clinical Variables at Diagnosis
Description	Clinical variables at Diagnosis included age,MM type(heavy/light chain...
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Participants are repeated for multiple CRAB signs and cytogenic abnormalities. Percentages were rounded off.


Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description:		Adult participants with a diagnosis...
Arm/Group Description:		Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed		276
Measure Type: Number Unit of Measure: percentage of participants
Age, Adults (27-90 years)	Number Analyzed	276 participants
Age, Adults (27-90 years)		100
MM Type, Heavy chain, IgA	Number Analyzed	266 participants
MM Type, Heavy chain, IgA		24.1
MM Type, Heavy chain, IgD	Number Analyzed	266 participants
MM Type, Heavy chain, IgD		1.9
MM Type, Heavy chain, IgG	Number Analyzed	266 participants
MM Type, Heavy chain, IgG		56.8
MM Type, Heavy chain, IgM	Number Analyzed	266 participants
MM Type, Heavy chain, IgM		0.8
MM Type, Heavy chain, No Heavy Chain	Number Analyzed	266 participants
MM Type, Heavy chain, No Heavy Chain		16.5
MM Type, Light Chain, No Light Chain	Number Analyzed	276 participants
MM Type, Light Chain, No Light Chain		3.3
MM Type, Light Chain, Kappa	Number Analyzed	276 participants
MM Type, Light Chain, Kappa		59.8
MM Type, Light Chain, Lambda	Number Analyzed	276 participants
MM Type, Light Chain, Lambda		37.0
MM Type, Bence Jones Protein, Yes	Number Analyzed	235 participants
MM Type, Bence Jones Protein, Yes		53.6
ISS Disease Stage I	Number Analyzed	267 participants
ISS Disease Stage I		28.8
ISS Disease Stage II	Number Analyzed	267 participants
ISS Disease Stage II		28.1
ISS Disease Stage III	Number Analyzed	267 participants
ISS Disease Stage III		43.1
CRAB Signs, None	Number Analyzed	276 participants
CRAB Signs, None		12.7
CRAB Signs, Some, Increase in blood calcium levels	Number Analyzed	241 participants
CRAB Signs, Some, Increase in blood calcium levels		12.0
CRAB Signs, Some, Renal failure	Number Analyzed	241 participants
CRAB Signs, Some, Renal failure		18.7
CRAB Signs, Some, Anemia	Number Analyzed	241 participants
CRAB Signs, Some, Anemia		52.7
CRAB Signs, Some, Bone lesions	Number Analyzed	241 participants
CRAB Signs, Some, Bone lesions		76.3
Cytogenetic abnormalities, t (4;14)	Number Analyzed	106 participants
Cytogenetic abnormalities, t (4;14)		11.3
Cytogenetic abnormalities, t (11;14)	Number Analyzed	106 participants
Cytogenetic abnormalities, t (11;14)		14.2
Cytogenetic abnormalities, t (14;16)	Number Analyzed	106 participants
Cytogenetic abnormalities, t (14;16)		1.9
Cytogenetic abnormalities, Trisomies	Number Analyzed	106 participants
Cytogenetic abnormalities, Trisomies		3.8
Cytogenetic abnormalities, d (17p)	Number Analyzed	106 participants
Cytogenetic abnormalities, d (17p)		17.9
Cytogenetic abnormalities, g (1q)	Number Analyzed	106 participants
Cytogenetic abnormalities, g (1q)		21.7
Cytogenetic abnormalities, Other	Number Analyzed	106 participants
Cytogenetic abnormalities, Other		66.0
Risk, High	Number Analyzed	106 participants
Risk, High		19.8
Risk, Standard	Number Analyzed	106 participants
Risk, Standard		12.3
Risk, Intermediate	Number Analyzed	106 participants
Risk, Intermediate		23.6
Risk, Other	Number Analyzed	106 participants
Risk, Other		44.3
ECOG Status, 0	Number Analyzed	195 participants
ECOG Status, 0		29.7
ECOG Status, 1	Number Analyzed	195 participants
ECOG Status, 1		41.5
ECOG Status, 2	Number Analyzed	195 participants
ECOG Status, 2		22.6
ECOG Status, 3	Number Analyzed	195 participants
ECOG Status, 3		6.2

3.Primary Outcome


Title	Percentage of MM Participants Categorized by Clinical Variables at Latest Symptomatic Relapse and/or Refractory Episode
Description	Clinical variables include date of latest symptomatic relapse and/or r...
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Participants are repeated across multiple categories. Percentages were rounded off.


Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description:		Adult participants with a diagnosis...
Arm/Group Description:		Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed		276
Measure Type: Number Unit of Measure: percentage of participants
Relapse Within 6 Months of Last Relapse	Number Analyzed	276 participants
Relapse Within 6 Months of Last Relapse		61.6
ISS Disease Stage I	Number Analyzed	211 participants
ISS Disease Stage I		37.4
ISS Disease Stage II	Number Analyzed	211 participants
ISS Disease Stage II		35.5
ISS Disease Stage III	Number Analyzed	211 participants
ISS Disease Stage III		27.0
CRAB Signs, None	Number Analyzed	276 participants
CRAB Signs, None		25.7
CRAB Signs, Some-Increase in blood calcium levels	Number Analyzed	205 participants
CRAB Signs, Some-Increase in blood calcium levels		9.3
CRAB Signs, Some-Renal Failure	Number Analyzed	205 participants
CRAB Signs, Some-Renal Failure		20.5
CRAB Signs, Some-Anemia	Number Analyzed	205 participants
CRAB Signs, Some-Anemia		43.9
CRAB Signs, Some-Bone lesions	Number Analyzed	205 participants
CRAB Signs, Some-Bone lesions		65.9
Cytogenetic Abnormalities, t(4;14)	Number Analyzed	87 participants
Cytogenetic Abnormalities, t(4;14)		11.5
Cytogenetic Abnormalities, t(11;14)	Number Analyzed	87 participants
Cytogenetic Abnormalities, t(11;14)		8.0
Cytogenetic Abnormalities, t(14;16)	Number Analyzed	87 participants
Cytogenetic Abnormalities, t(14;16)		5.7
Cytogenetic Abnormalities, Trisomies	Number Analyzed	87 participants
Cytogenetic Abnormalities, Trisomies		4.6
Cytogenetic Abnormalities, d (17p)	Number Analyzed	87 participants
Cytogenetic Abnormalities, d (17p)		19.5
Cytogenetic Abnormalities, g (1q)	Number Analyzed	87 participants
Cytogenetic Abnormalities, g (1q)		27.96
Cytogenetic Abnormalities, other	Number Analyzed	87 participants
Cytogenetic Abnormalities, other		64.4
Risk, High	Number Analyzed	49 participants
Risk, High		38.8
Risk, Standard	Number Analyzed	49 participants
Risk, Standard		12.2
Risk, Intermediate	Number Analyzed	49 participants
Risk, Intermediate		49.0
Diffuse osteopathy	Number Analyzed	272 participants
Diffuse osteopathy		15.4
Fractures	Number Analyzed	276 participants
Fractures		15.2
Neurological symptoms	Number Analyzed	276 participants
Neurological symptoms		8.0
Infections	Number Analyzed	276 participants
Infections		15.2
Comorbidities, Diabetes	Number Analyzed	175 participants
Comorbidities, Diabetes		24.6
Comorbidities, Neuropathy	Number Analyzed	175 participants
Comorbidities, Neuropathy		20.6
Comorbidities, Nephropathy	Number Analyzed	175 participants
Comorbidities, Nephropathy		15.4
Comorbidity, COPD	Number Analyzed	175 participants
Comorbidity, COPD		11.4
Comorbidities, Cardiovascular disease	Number Analyzed	175 participants
Comorbidities, Cardiovascular disease		48.6
Comorbidities, Liver failure	Number Analyzed	175 participants
Comorbidities, Liver failure		1.7
Comorbidities,Psychiatric or Neurological Disorder	Number Analyzed	175 participants
Comorbidities,Psychiatric or Neurological Disorder		14.3
Comorbidities, Other secondary disorders	Number Analyzed	175 participants
Comorbidities, Other secondary disorders		45.7
Medullary Plasmacytoma	Number Analyzed	276 participants
Medullary Plasmacytoma		15.3
Extramedullary Plasmacytoma	Number Analyzed	276 participants
Extramedullary Plasmacytoma		15.6
Anti-CD38 mAb Monotherapy, Second Line	Number Analyzed	112 participants
Anti-CD38 mAb Monotherapy, Second Line		0.9
Anti-CD38 mAb Monotherapy, Third Line	Number Analyzed	68 participants
Anti-CD38 mAb Monotherapy, Third Line		13.2
Anti-CD38 mAb Monotherapy, Fourth Line or Later	Number Analyzed	79 participants
Anti-CD38 mAb Monotherapy, Fourth Line or Later		20.3
Double PI Therapy+Steroids/Alkylating Agent,2 Line	Number Analyzed	112 participants
Double PI Therapy+Steroids/Alkylating Agent,2 Line		9.8
Double PI therapy+Steroids/Alkylating Agent,3 Line	Number Analyzed	68 participants
Double PI therapy+Steroids/Alkylating Agent,3 Line		10.3
DoublePI Therapy+Steroids/Alkylating Agent,>=4Line	Number Analyzed	79 participants
DoublePI Therapy+Steroids/Alkylating Agent,>=4Line		6.3
Autologous transplant, Second Line	Number Analyzed	119 participants
Autologous transplant, Second Line		2.5
Autologous transplant, Third Line	Number Analyzed	71 participants
Autologous transplant, Third Line		7.0
Autologous transplant, Fourth Line or Later	Number Analyzed	85 participants
Autologous transplant, Fourth Line or Later		1.2
Allogeneic transplant, Second Line	Number Analyzed	119 participants
Allogeneic transplant, Second Line		0.8
Allogeneic transplant, Third Line	Number Analyzed	71 participants
Allogeneic transplant, Third Line		1.4
Allogeneic transplant, Fourth Line or Later	Number Analyzed	85 participants
Allogeneic transplant, Fourth Line or Later		2.4
Autologous or Allogeneic Transplant, Second Line	Number Analyzed	119 participants
Autologous or Allogeneic Transplant, Second Line		2.5
Autologous or Allogeneic Transplant, Third Line	Number Analyzed	71 participants
Autologous or Allogeneic Transplant, Third Line		8.5
Autologous or Allogeneic Transplant, >=4 Lines	Number Analyzed	85 participants
Autologous or Allogeneic Transplant, >=4 Lines		3.5

4.Secondary Outcome


Title	Percentage of MM Participants With Clinical and Sociodemographic Characteristics Categorized by Treatment Selection at the Latest Symptomatic Relapse and/or Refractory Episode
Description	Clinical and Sociodemographic variables categorized by treatment selec...
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category. Percentages were rounded off.


Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description:		Adult participants with a diagnosis...
Arm/Group Description:		Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed		276
Measure Type: Number Unit of Measure: percentage of participants
Age, 38-85 years, IMiDs	Number Analyzed	89 participants
Age, 38-85 years, IMiDs		100
Age, 43-76 years, PI + IMiDs	Number Analyzed	49 participants
Age, 43-76 years, PI + IMiDs		100
Age, 47-84 years, PI	Number Analyzed	34 participants
Age, 47-84 years, PI		100
Age, 39-80 years, mAb	Number Analyzed	61 participants
Age, 39-80 years, mAb		100
Age, 53-90 years, Other	Number Analyzed	26 participants
Age, 53-90 years, Other		100
Sex, Male, IMiDs	Number Analyzed	89 participants
Sex, Male, IMiDs		49.4
Sex, Female, IMiDs	Number Analyzed	89 participants
Sex, Female, IMiDs		50.6
Sex, Male, PI + IMiDs	Number Analyzed	49 participants
Sex, Male, PI + IMiDs		61.2
Sex, Female, PI + IMiDs	Number Analyzed	49 participants
Sex, Female, PI + IMiDs		38.8
Sex, Male, PI	Number Analyzed	34 participants
Sex, Male, PI		47.1
Sex, Female, PI	Number Analyzed	34 participants
Sex, Female, PI		52.9
Sex, Male, mAb	Number Analyzed	61 participants
Sex, Male, mAb		55.7
Sex, Female, mAb	Number Analyzed	61 participants
Sex, Female, mAb		44.3
Sex, Male, Other	Number Analyzed	26 participants
Sex, Male, Other		57.7
Sex, Female, Other	Number Analyzed	26 participants
Sex, Female, Other		42.3
Prior lines of treatment, 1, IMiDs	Number Analyzed	89 participants
Prior lines of treatment, 1, IMiDs		50.6
Prior lines of treatment, 2, IMiDs	Number Analyzed	89 participants
Prior lines of treatment, 2, IMiDs		28.1
Prior lines of treatment, 3 or more, IMiDs	Number Analyzed	89 participants
Prior lines of treatment, 3 or more, IMiDs		21.3
Prior lines of treatment, 1, PI + IMiDs	Number Analyzed	49 participants
Prior lines of treatment, 1, PI + IMiDs		63.3
Prior lines of treatment, 2, PI + IMiDs	Number Analyzed	49 participants
Prior lines of treatment, 2, PI + IMiDs		16.3
Prior lines of treatment, 3 or more, PI + IMiDs	Number Analyzed	49 participants
Prior lines of treatment, 3 or more, PI + IMiDs		20.4
Prior lines of treatment, 1, PI	Number Analyzed	34 participants
Prior lines of treatment, 1, PI		44.1
Prior lines of treatment, 2, PI	Number Analyzed	34 participants
Prior lines of treatment, 2, PI		35.3
Prior lines of treatment, 3 or more, PI	Number Analyzed	34 participants
Prior lines of treatment, 3 or more, PI		20.6
Prior lines of treatment, 1, mAb	Number Analyzed	61 participants
Prior lines of treatment, 1, mAb		26.2
Prior lines of treatment, 2, mAb	Number Analyzed	61 participants
Prior lines of treatment, 2, mAb		29.5
Prior lines of treatment, 3 or more, mAb	Number Analyzed	61 participants
Prior lines of treatment, 3 or more, mAb		44.3
Prior lines of treatment, 1, Other	Number Analyzed	26 participants
Prior lines of treatment, 1, Other		11.5
Prior lines of treatment, 2, Other	Number Analyzed	26 participants
Prior lines of treatment, 2, Other		26.9
Prior lines of treatment, 3 or more, Other	Number Analyzed	26 participants
Prior lines of treatment, 3 or more, Other		61.5
Number of prior relapses, 0, IMiDs	Number Analyzed	89 participants
Number of prior relapses, 0, IMiDs		43.8
Number of prior relapses, 1, IMiDs	Number Analyzed	89 participants
Number of prior relapses, 1, IMiDs		31.5
Number of prior relapses, 2, IMiDs	Number Analyzed	89 participants
Number of prior relapses, 2, IMiDs		12.4
Number of prior relapses, 3 and more, IMiDs	Number Analyzed	89 participants
Number of prior relapses, 3 and more, IMiDs		12.4
Number of prior relapses, 0, PI + IMiDs	Number Analyzed	49 participants
Number of prior relapses, 0, PI + IMiDs		49.0
Number of prior relapses, 1, PI + IMiDs	Number Analyzed	49 participants
Number of prior relapses, 1, PI + IMiDs		36.7
Number of prior relapses, 2, PI + IMiDs	Number Analyzed	49 participants
Number of prior relapses, 2, PI + IMiDs		2.0
Number of prior relapses, 3 or more, PI + IMiDs	Number Analyzed	49 participants
Number of prior relapses, 3 or more, PI + IMiDs		12.2
Number of prior relapses, 0, PI	Number Analyzed	34 participants
Number of prior relapses, 0, PI		47.1
Number of prior relapses, 1, PI	Number Analyzed	34 participants
Number of prior relapses, 1, PI		32.4
Number of prior relapses, 2, PI	Number Analyzed	34 participants
Number of prior relapses, 2, PI		2.9
Number of prior relapses, 3 or more, PI	Number Analyzed	34 participants
Number of prior relapses, 3 or more, PI		17.6
Number of prior relapses, 0, mAb	Number Analyzed	61 participants
Number of prior relapses, 0, mAb		27.9
Number of prior relapses, 1, mAb	Number Analyzed	61 participants
Number of prior relapses, 1, mAb		26.2
Number of prior relapses, 2, mAb	Number Analyzed	61 participants
Number of prior relapses, 2, mAb		18.0
Number of prior relapses, 3 or more, mAb	Number Analyzed	61 participants
Number of prior relapses, 3 or more, mAb		27.9
Number of prior relapses, 0, Other	Number Analyzed	26 participants
Number of prior relapses, 0, Other		11.5
Number of prior relapses, 1, Other	Number Analyzed	26 participants
Number of prior relapses, 1, Other		26.9
Number of prior relapses, 2, Other	Number Analyzed	26 participants
Number of prior relapses, 2, Other		23.1
Number of prior relapses, 3 or more, Other	Number Analyzed	26 participants
Number of prior relapses, 3 or more, Other		38.5
ISS Disease Stage I, IMiDs	Number Analyzed	65 participants
ISS Disease Stage I, IMiDs		38.5
ISS Disease Stage II, IMiDs	Number Analyzed	65 participants
ISS Disease Stage II, IMiDs		38.5
ISS Disease Stage III, IMiDs	Number Analyzed	65 participants
ISS Disease Stage III, IMiDs		23.1
ISS Disease Stage I, PI + IMiDs	Number Analyzed	39 participants
ISS Disease Stage I, PI + IMiDs		51.3
ISS Disease Stage II, PI + IMiDs	Number Analyzed	39 participants
ISS Disease Stage II, PI + IMiDs		28.2
ISS Disease Stage III, PI + IMiDs	Number Analyzed	39 participants
ISS Disease Stage III, PI + IMiDs		20.5
ISS Disease Stage I, PI	Number Analyzed	24 participants
ISS Disease Stage I, PI		20.8
ISS Disease Stage II, PI	Number Analyzed	24 participants
ISS Disease Stage II, PI		54.2
ISS Disease Stage III, PI	Number Analyzed	24 participants
ISS Disease Stage III, PI		25.0
ISS Disease Stage I, mAb	Number Analyzed	50 participants
ISS Disease Stage I, mAb		40.0
ISS Disease Stage II, mAb	Number Analyzed	50 participants
ISS Disease Stage II, mAb		32.0
ISS Disease Stage III, mAb	Number Analyzed	50 participants
ISS Disease Stage III, mAb		28.0
ISS Disease Stage I, Other	Number Analyzed	21 participants
ISS Disease Stage I, Other		23.8
ISS Disease Stage II, Other	Number Analyzed	21 participants
ISS Disease Stage II, Other		23.8
ISS Disease Stage III, Other	Number Analyzed	21 participants
ISS Disease Stage III, Other		52.4
CRAB Signs, None, IMiDs	Number Analyzed	89 participants
CRAB Signs, None, IMiDs		29.2
CRAB Signs, Some, IMiDs	Number Analyzed	89 participants
CRAB Signs, Some, IMiDs		70.8
CRAB Signs, None, PI + IMiDs	Number Analyzed	49 participants
CRAB Signs, None, PI + IMiDs		14.3
CRAB Signs, Some, PI + IMiDs	Number Analyzed	49 participants
CRAB Signs, Some, PI + IMiDs		85.7
CRAB Signs, None, PI	Number Analyzed	34 participants
CRAB Signs, None, PI		20.6
CRAB Signs, Some, PI	Number Analyzed	34 participants
CRAB Signs, Some, PI		79.4
CRAB Signs, None, mAb	Number Analyzed	61 participants
CRAB Signs, None, mAb		31.1
CRAB Signs, Some, mAb	Number Analyzed	61 participants
CRAB Signs, Some, mAb		68.9
CRAB Signs, None, Other	Number Analyzed	26 participants
CRAB Signs, None, Other		23.1
CRAB Signs, Some, Other	Number Analyzed	26 participants
CRAB Signs, Some, Other		76.9
Comorbidities, None, IMiDs	Number Analyzed	89 participants
Comorbidities, None, IMiDs		41.6
Comorbidities, Some, IMiDs	Number Analyzed	89 participants
Comorbidities, Some, IMiDs		58.4
Comorbidities, None, PI + IMiDs	Number Analyzed	49 participants
Comorbidities, None, PI + IMiDs		49.0
Comorbidities, Some, PI + IMiDs	Number Analyzed	49 participants
Comorbidities, Some, PI + IMiDs		51.0
Comorbidities, None, PI	Number Analyzed	34 participants
Comorbidities, None, PI		35.3
Comorbidities, Some, PI	Number Analyzed	34 participants
Comorbidities, Some, PI		64.7
Comorbidities, None, mAb	Number Analyzed	61 participants
Comorbidities, None, mAb		32.8
Comorbidities, Some, mAb	Number Analyzed	61 participants
Comorbidities, Some, mAb		67.2
Comorbidities, None, Other	Number Analyzed	26 participants
Comorbidities, None, Other		23.1
Comorbidities, Some, Other	Number Analyzed	26 participants
Comorbidities, Some, Other		76.9
Risk, High, IMiDs	Number Analyzed	10 participants
Risk, High, IMiDs		50.0
Risk, Standard, IMiDs	Number Analyzed	10 participants
Risk, Standard, IMiDs		50.0
Risk, High, PI + IMiDs	Number Analyzed	12 participants
Risk, High, PI + IMiDs		41.7
Risk, Standard, PI + IMiDs	Number Analyzed	12 participants
Risk, Standard, PI + IMiDs		58.3
Risk, High, PI	Number Analyzed	4 participants
Risk, High, PI		50.0
Risk, Standard, PI	Number Analyzed	4 participants
Risk, Standard, PI		50.0
Risk, High, mAb	Number Analyzed	15 participants
Risk, High, mAb		60.0
Risk, Standard, mAb	Number Analyzed	15 participants
Risk, Standard, mAb		40.0
Risk, High, Other	Number Analyzed	4 participants
Risk, High, Other		50.0
Risk, Standard, Other	Number Analyzed	4 participants
Risk, Standard, Other		50.0
Medullary Plasmacytoma, Yes, IMiDs	Number Analyzed	84 participants
Medullary Plasmacytoma, Yes, IMiDs		15.5
Medullary Plasmacytoma, No, IMiDs	Number Analyzed	84 participants
Medullary Plasmacytoma, No, IMiDs		84.5
Medullary Plasmacytoma, Yes, PI + IMiDs	Number Analyzed	44 participants
Medullary Plasmacytoma, Yes, PI + IMiDs		25.0
Medullary Plasmacytoma, No, PI + IMiDs	Number Analyzed	44 participants
Medullary Plasmacytoma, No, PI + IMiDs		75.0
Medullary Plasmacytoma, Yes, PI	Number Analyzed	34 participants
Medullary Plasmacytoma, Yes, PI		14.7
Medullary Plasmacytoma, No, PI	Number Analyzed	34 participants
Medullary Plasmacytoma, No, PI		85.3
Medullary Plasmacytoma, Yes, mAb	Number Analyzed	58 participants
Medullary Plasmacytoma, Yes, mAb		8.6
Medullary Plasmacytoma, No, mAb	Number Analyzed	58 participants
Medullary Plasmacytoma, No, mAb		91.4
Medullary Plasmacytoma, Yes, Other	Number Analyzed	25 participants
Medullary Plasmacytoma, Yes, Other		16.0
Medullary Plasmacytoma, No, Other	Number Analyzed	25 participants
Medullary Plasmacytoma, No, Other		84.0
Extramedullary Plasmacytoma, Yes, IMiDs	Number Analyzed	86 participants
Extramedullary Plasmacytoma, Yes, IMiDs		12.8
Extramedullary Plasmacytoma, No, IMiDs	Number Analyzed	86 participants
Extramedullary Plasmacytoma, No, IMiDs		87.2
Extramedullary Plasmacytoma, Yes, PI + IMiDs	Number Analyzed	48 participants
Extramedullary Plasmacytoma, Yes, PI + IMiDs		33.3
Extramedullary Plasmacytoma, No, PI + IMiDs	Number Analyzed	48 participants
Extramedullary Plasmacytoma, No, PI + IMiDs		66.7
Extramedullary Plasmacytoma, Yes, PI	Number Analyzed	34 participants
Extramedullary Plasmacytoma, Yes, PI		11.8
Extramedullary Plasmacytoma, No, PI	Number Analyzed	34 participants
Extramedullary Plasmacytoma, No, PI		88.2
Extramedullary Plasmacytoma, Yes, mAb	Number Analyzed	60 participants
Extramedullary Plasmacytoma, Yes, mAb		6.7
Extramedullary Plasmacytoma, No, mAb	Number Analyzed	60 participants
Extramedullary Plasmacytoma, No, mAb		93.3
Extramedullary Plasmacytoma, Yes, Other	Number Analyzed	25 participants
Extramedullary Plasmacytoma, Yes, Other		24.0
Extramedullary Plasmacytoma, No, Other	Number Analyzed	25 participants
Extramedullary Plasmacytoma, No, Other		76.0
Osteopenia, Yes, IMiDs	Number Analyzed	88 participants
Osteopenia, Yes, IMiDs		23.9
Osteopenia, No, IMiDs	Number Analyzed	88 participants
Osteopenia, No, IMiDs		76.1
Osteopenia, Yes, PI + IMiDs	Number Analyzed	48 participants
Osteopenia, Yes, PI + IMiDs		6.3
Osteopenia, No, PI + IMiDs	Number Analyzed	48 participants
Osteopenia, No, PI + IMiDs		93.8
Osteopenia, Yes, PI	Number Analyzed	34 participants
Osteopenia, Yes, PI		8.8
Osteopenia, No, PI	Number Analyzed	34 participants
Osteopenia, No, PI		91.2
Osteopenia, Yes, mAb	Number Analyzed	60 participants
Osteopenia, Yes, mAb		13.3
Osteopenia, No, mAb	Number Analyzed	60 participants
Osteopenia, No, mAb		86.7
Osteopenia, Yes, Other	Number Analyzed	26 participants
Osteopenia, Yes, Other		23.1
Osteopenia, No, Other	Number Analyzed	26 participants
Osteopenia, No, Other		76.9
Fractures, Yes, IMiDs	Number Analyzed	89 participants
Fractures, Yes, IMiDs		15.7
Fractures, No, IMiDs	Number Analyzed	89 participants
Fractures, No, IMiDs		84.3
Fractures, Yes, PI + IMiDs	Number Analyzed	49 participants
Fractures, Yes, PI + IMiDs		18.4
Fractures, No, PI + IMiDs	Number Analyzed	49 participants
Fractures, No, PI + IMiDs		81.6
Fractures, Yes, PI	Number Analyzed	34 participants
Fractures, Yes, PI		11.8
Fractures, No, PI	Number Analyzed	34 participants
Fractures, No, PI		88.2
Fractures, Yes, mAb	Number Analyzed	61 participants
Fractures, Yes, mAb		14.8
Fractures, No, mAb	Number Analyzed	61 participants
Fractures, No, mAb		85.2
Fractures, Yes, Other	Number Analyzed	26 participants
Fractures, Yes, Other		15.4
Fractures, No, Other	Number Analyzed	26 participants
Fractures, No, Other		84.6
Neurological Symptoms, Yes, IMiDs	Number Analyzed	89 participants
Neurological Symptoms, Yes, IMiDs		10.1
Neurological Symptoms, No, IMiDs	Number Analyzed	89 participants
Neurological Symptoms, No, IMiDs		89.9
Neurological Symptoms, Yes, PI + IMiDs	Number Analyzed	49 participants
Neurological Symptoms, Yes, PI + IMiDs		10.2
Neurological Symptoms, No, PI + IMiDs	Number Analyzed	49 participants
Neurological Symptoms, No, PI + IMiDs		89.8
Neurological Symptoms, Yes, PI	Number Analyzed	34 participants
Neurological Symptoms, Yes, PI		5.9
Neurological Symptoms, No, PI	Number Analyzed	34 participants
Neurological Symptoms, No, PI		94.1
Neurological Symptoms, Yes, mAb	Number Analyzed	61 participants
Neurological Symptoms, Yes, mAb		1.6
Neurological Symptoms, No, mAb	Number Analyzed	61 participants
Neurological Symptoms, No, mAb		98.4
Neurological Symptoms, Yes, Other	Number Analyzed	26 participants
Neurological Symptoms, Yes, Other		11.5
Neurological Symptoms, No, Other	Number Analyzed	26 participants
Neurological Symptoms, No, Other		88.5
MM Related Neurological Symptoms, Yes, IMiDs	Number Analyzed	89 participants
MM Related Neurological Symptoms, Yes, IMiDs		5.6
MM Related Neurological Symptoms, No, IMiDs	Number Analyzed	89 participants
MM Related Neurological Symptoms, No, IMiDs		94.4
MM Related Neurological Symptoms, Yes, PI + IMiDs	Number Analyzed	49 participants
MM Related Neurological Symptoms, Yes, PI + IMiDs		8.2
MM Related Neurological Symptoms, No, PI + IMiDs	Number Analyzed	49 participants
MM Related Neurological Symptoms, No, PI + IMiDs		91.8
MM Related Neurological Symptoms, Yes, PI	Number Analyzed	34 participants
MM Related Neurological Symptoms, Yes, PI		5.9
MM Related Neurological Symptoms, No, PI	Number Analyzed	34 participants
MM Related Neurological Symptoms, No, PI		94.1
MM Related Neurological Symptoms, Yes, mAb	Number Analyzed	61 participants
MM Related Neurological Symptoms, Yes, mAb		0.0
MM Related Neurological Symptoms, No, mAb	Number Analyzed	61 participants
MM Related Neurological Symptoms, No, mAb		100.0
MM Related Neurological Symptoms, Yes, Other	Number Analyzed	26 participants
MM Related Neurological Symptoms, Yes, Other		7.7
MM Related Neurological Symptoms, No, Other	Number Analyzed	26 participants
MM Related Neurological Symptoms, No, Other		92.3
Infections, Yes, IMiDs	Number Analyzed	89 participants
Infections, Yes, IMiDs		14.6
Infections, No, IMiDs	Number Analyzed	89 participants
Infections, No, IMiDs		85.4
Infections, Yes, PI + IMiDs	Number Analyzed	49 participants
Infections, Yes, PI + IMiDs		20.4
Infections, No, PI + IMiDs	Number Analyzed	49 participants
Infections, No, PI + IMiDs		79.6
Infections, Yes, PI	Number Analyzed	34 participants
Infections, Yes, PI		14.7
Infections, No, PI	Number Analyzed	34 participants
Infections, No, PI		85.3
Infections, Yes, mAb	Number Analyzed	61 participants
Infections, Yes, mAb		11.5
Infections, No, mAb	Number Analyzed	61 participants
Infections, No, mAb		88.5
Infections, Yes, Other	Number Analyzed	26 participants
Infections, Yes, Other		11.5
Infections, No, Other	Number Analyzed	26 participants
Infections, No, Other		88.5

5.Secondary Outcome


Title	Number of New Relevant Variables That Are Not Currently Collected in Clinical Records and That Could Influence in the Disease Management at Relapse
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome measure.


Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description:	Adult participants with a diagnosis...
Arm/Group Description:	Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed	0
Overall Number of Units Analyzed Type of Units Analyzed: Variables	0

No data displayed because Outcome Measure has zero total analyzed.

6.Secondary Outcome


Title	Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
Description	The EORTC QLQ-C30 contains 30 items across 5 functional scales (physic...
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.


Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description:	Adult participants with a diagnosis...
Arm/Group Description:	Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed	273
Mean (Standard Deviation) Unit of Measure: score on a scale
	53.5 (23.9)

7.Secondary Outcome


Title	HRQOL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Subscale Score
Description	The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 func...
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Overall number of participants analyzed are the participants with data available for analyses.


Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description:	Adult participants with a diagnosis...
Arm/Group Description:	Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed	273
Mean (Standard Deviation) Unit of Measure: score on scale
Future perspective	58.4 (27.7)
Body image	72.9 (34.4)
Symptoms of the disease	30.7 (23.2)
Adverse effects of the treatment	25.4 (17.2)

8.Secondary Outcome


Title	HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
Description	The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 func...
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category.


Arm/Group Title		Multiple Myeloma (MM) Participants
Arm/Group Description:		Adult participants with a diagnosis...
Arm/Group Description:		Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed		276
Mean (Standard Deviation) Unit of Measure: score on a scale
Future perspective, Factors I-II	Number Analyzed	142 participants
Future perspective, Factors I-II		60.3 (28.2)
Future perspective, Factors III	Number Analyzed	53 participants
Future perspective, Factors III		53.9 (24.9)
Body image, Factors I-II	Number Analyzed	142 participants
Body image, Factors I-II		73.9 (35.5)
Body image, Factors III	Number Analyzed	53 participants
Body image, Factors III		73.0 (32.7)
Symptoms of the disease, Factors I-II	Number Analyzed	142 participants
Symptoms of the disease, Factors I-II		31.9 (23.6)
Symptoms of the disease, Factors III	Number Analyzed	53 participants
Symptoms of the disease, Factors III		27.3 (22.1)
Adverse effects of the treatment, Factors I-II	Number Analyzed	142 participants
Adverse effects of the treatment, Factors I-II		24.3 (16.9)
Adverse effects of the treatment, Factors III	Number Analyzed	53 participants
Adverse effects of the treatment, Factors III		29.0 (17.5)

9.Secondary Outcome


Title	Percentage of Participants With Health Care Resource Utilization (HU)
Description	Healthcare resources used during medical encounters include intensive ...
Description	Healthcare resources used during medical encounters include intensive care unit (ICU) admissions, hospital admissions, visits to the emergency room, days admitted.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All participants eligible for analyses were included.


Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description:	Adult participants with a diagnosis...
Arm/Group Description:	Adult participants with a diagnosis of MM 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.
Overall Number of Participants Analyzed	276
Measure Type: Number Unit of Measure: percentage of participants
Admitted at some healthcare service	56.2
Admitted to Hospital	59.4
Used ambulance to attend to the hospital	7.0
Used their own transport	67.8
Consultation with the primary care physician	21.7
Consultation with the oncologist	2.5
Consultation with the psychologist	3.6
Attended psychologist	60
Attended hematologist	89.1
Required some test	82.2
Had undergone X-ray test	43.2

Adverse Events

Time Frame	From enrollment on 26 July 2017 to last date of assessment 30 January 2019 (Up to 1.5 years)
Adverse Event Reporting Description	Data of adverse events or adverse drug reactions were not collected as part of the study database.

Arm/Group Title	Multiple Myeloma (MM) Participants
Arm/Group Description	Adult participants with a diagnosis...
Arm/Group Description	Adult participants with a diagnosis of MM 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.
All-Cause Mortality
	Multiple Myeloma (MM) Participants
	Affected / at Risk (%)
Total	0/276 (0.00%)
Serious Adverse Events Serious Adverse Events
	Multiple Myeloma (MM) Participants
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Multiple Myeloma (MM) Participants
	Affected / at Risk (%)
Total	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Director
Organization:	Takeda
Phone:	+1-877-825-3327
EMail:	trialdisclosures@takeda.com

Layout table for additonal information

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT03188536
Other Study ID Numbers:	RRMM-5012 TAK-MMR-2017-01 ( Registry Identifier: Spanish health authority )
First Submitted:	June 12, 2017
First Posted:	June 15, 2017
Results First Submitted:	August 17, 2020
Results First Posted:	October 12, 2020
Last Update Posted:	October 12, 2020

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