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NCT03188536 · OUTCOME

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

Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study) · Source last updated 2020-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Day 1

What was measured

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.

Analysis population: 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.

Groups in this outcome

Multiple Myeloma (MM) Participants

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Reported measurements

Relapse Within 6 Months of Last Relapse

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	61.6	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage I

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	211

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	37.4	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage II

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	211

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	35.5	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage III

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	211

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	27.0	Not reported	Not reported	Not reported	Not reported

CRAB Signs, None

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	25.7	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some-Increase in blood calcium levels

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	205

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	9.3	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some-Renal Failure

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	205

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	20.5	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some-Anemia

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	205

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	43.9	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some-Bone lesions

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	205

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	65.9	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, t(4;14)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	11.5	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, t(11;14)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	8.0	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, t(14;16)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	5.7	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, Trisomies

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	4.6	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, d (17p)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	19.5	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, g (1q)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	27.96	Not reported	Not reported	Not reported	Not reported

Cytogenetic Abnormalities, other

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	87

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	64.4	Not reported	Not reported	Not reported	Not reported

Risk, High

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	49

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	38.8	Not reported	Not reported	Not reported	Not reported

Risk, Standard

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	49

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	12.2	Not reported	Not reported	Not reported	Not reported

Risk, Intermediate

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	49

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	49.0	Not reported	Not reported	Not reported	Not reported

Diffuse osteopathy

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	272

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.4	Not reported	Not reported	Not reported	Not reported

Fractures

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.2	Not reported	Not reported	Not reported	Not reported

Neurological symptoms

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	8.0	Not reported	Not reported	Not reported	Not reported

Infections

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.2	Not reported	Not reported	Not reported	Not reported

Comorbidities, Diabetes

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	24.6	Not reported	Not reported	Not reported	Not reported

Comorbidities, Neuropathy

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	20.6	Not reported	Not reported	Not reported	Not reported

Comorbidities, Nephropathy

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.4	Not reported	Not reported	Not reported	Not reported

Comorbidity, COPD

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	11.4	Not reported	Not reported	Not reported	Not reported

Comorbidities, Cardiovascular disease

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	48.6	Not reported	Not reported	Not reported	Not reported

Comorbidities, Liver failure

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	1.7	Not reported	Not reported	Not reported	Not reported

Comorbidities,Psychiatric or Neurological Disorder

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	14.3	Not reported	Not reported	Not reported	Not reported

Comorbidities, Other secondary disorders

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	175

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	45.7	Not reported	Not reported	Not reported	Not reported

Medullary Plasmacytoma

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.3	Not reported	Not reported	Not reported	Not reported

Extramedullary Plasmacytoma

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	276

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	15.6	Not reported	Not reported	Not reported	Not reported

Anti-CD38 mAb Monotherapy, Second Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	112

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	0.9	Not reported	Not reported	Not reported	Not reported

Anti-CD38 mAb Monotherapy, Third Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	68

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	13.2	Not reported	Not reported	Not reported	Not reported

Anti-CD38 mAb Monotherapy, Fourth Line or Later

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	79

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	20.3	Not reported	Not reported	Not reported	Not reported

Double PI Therapy+Steroids/Alkylating Agent,2 Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	112

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	9.8	Not reported	Not reported	Not reported	Not reported

Double PI therapy+Steroids/Alkylating Agent,3 Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	68

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	10.3	Not reported	Not reported	Not reported	Not reported

DoublePI Therapy+Steroids/Alkylating Agent,>=4Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	79

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	6.3	Not reported	Not reported	Not reported	Not reported

Autologous transplant, Second Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	119

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	2.5	Not reported	Not reported	Not reported	Not reported

Autologous transplant, Third Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	71

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	7.0	Not reported	Not reported	Not reported	Not reported

Autologous transplant, Fourth Line or Later

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	85

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	1.2	Not reported	Not reported	Not reported	Not reported

Allogeneic transplant, Second Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	119

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	0.8	Not reported	Not reported	Not reported	Not reported

Allogeneic transplant, Third Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	71

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	1.4	Not reported	Not reported	Not reported	Not reported

Allogeneic transplant, Fourth Line or Later

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	85

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	2.4	Not reported	Not reported	Not reported	Not reported

Autologous or Allogeneic Transplant, Second Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	119

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	2.5	Not reported	Not reported	Not reported	Not reported

Autologous or Allogeneic Transplant, Third Line

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	71

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	8.5	Not reported	Not reported	Not reported	Not reported

Autologous or Allogeneic Transplant, >=4 Lines

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	85

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	3.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
61.6
denoms
counts
group Id
OG000
value
276
units
Participants
title
Relapse Within 6 Months of Last Relapse
categories
measurements
group Id
OG000
value
37.4
denoms
counts
group Id
OG000
value
211
units
Participants
title
ISS Disease Stage I
categories
measurements
group Id
OG000
value
35.5
denoms
counts
group Id
OG000
value
211
units
Participants
title
ISS Disease Stage II
categories
measurements
group Id
OG000
value
27.0
denoms
counts
group Id
OG000
value
211
units
Participants
title
ISS Disease Stage III
categories
measurements
group Id
OG000
value
25.7
denoms
counts
group Id
OG000
value
276
units
Participants
title
CRAB Signs, None
categories
measurements
group Id
OG000
value
9.3
denoms
counts
group Id
OG000
value
205
units
Participants
title
CRAB Signs, Some-Increase in blood calcium levels
categories
measurements
group Id
OG000
value
20.5
denoms
counts
group Id
OG000
value
205
units
Participants
title
CRAB Signs, Some-Renal Failure
categories
measurements
group Id
OG000
value
43.9
denoms
counts
group Id
OG000
value
205
units
Participants
title
CRAB Signs, Some-Anemia
categories
measurements
group Id
OG000
value
65.9
denoms
counts
group Id
OG000
value
205
units
Participants
title
CRAB Signs, Some-Bone lesions
categories
measurements
group Id
OG000
value
11.5
denoms
counts
group Id
OG000
value
87
units
Participants
title
Cytogenetic Abnormalities, t(4;14)
categories
measurements
group Id
OG000
value
8.0
denoms
counts
group Id
OG000
value
87
units
Participants
title
Cytogenetic Abnormalities, t(11;14)
categories
measurements
group Id
OG000
value
5.7
denoms
counts
group Id
OG000
value
87
units
Participants
title
Cytogenetic Abnormalities, t(14;16)

denoms

counts
group Id
OG000
value
276
units
Participants

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.

groups

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.
id
OG000
title
Multiple Myeloma (MM) Participants

param Type

NUMBER

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.

reporting Status

POSTED

time Frame

Day 1

title

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

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice