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NCT03188536 · OUTCOME

Percentage of MM Participants Categorized by Clinical Variables at Diagnosis

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 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).

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 for multiple CRAB signs and cytogenic abnormalities. 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

Age, Adults (27-90 years)

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	100	Not reported	Not reported	Not reported	Not reported

MM Type, Heavy chain, IgA

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	266

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	24.1	Not reported	Not reported	Not reported	Not reported

MM Type, Heavy chain, IgD

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	266

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	1.9	Not reported	Not reported	Not reported	Not reported

MM Type, Heavy chain, IgG

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	266

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	56.8	Not reported	Not reported	Not reported	Not reported

MM Type, Heavy chain, IgM

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	266

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

MM Type, Heavy chain, No Heavy Chain

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	266

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	16.5	Not reported	Not reported	Not reported	Not reported

MM Type, Light Chain, No Light Chain

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	3.3	Not reported	Not reported	Not reported	Not reported

MM Type, Light Chain, Kappa

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	59.8	Not reported	Not reported	Not reported	Not reported

MM Type, Light Chain, Lambda

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	37.0	Not reported	Not reported	Not reported	Not reported

MM Type, Bence Jones Protein, Yes

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	235

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	53.6	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage I

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	267

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	28.8	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage II

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	267

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	28.1	Not reported	Not reported	Not reported	Not reported

ISS Disease Stage III

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	267

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	43.1	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	12.7	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	241

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	12.0	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some, Renal failure

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	241

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	18.7	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some, Anemia

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	241

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	52.7	Not reported	Not reported	Not reported	Not reported

CRAB Signs, Some, Bone lesions

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	241

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	76.3	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, t (4;14)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	11.3	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, t (11;14)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	14.2	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, t (14;16)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	1.9	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, Trisomies

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	3.8	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, d (17p)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	17.9	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, g (1q)

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	21.7	Not reported	Not reported	Not reported	Not reported

Cytogenetic abnormalities, Other

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	66.0	Not reported	Not reported	Not reported	Not reported

Risk, High

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	19.8	Not reported	Not reported	Not reported	Not reported

Risk, Standard

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	12.3	Not reported	Not reported	Not reported	Not reported

Risk, Intermediate

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	23.6	Not reported	Not reported	Not reported	Not reported

Risk, Other

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	106

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	44.3	Not reported	Not reported	Not reported	Not reported

ECOG Status, 0

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	195

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	29.7	Not reported	Not reported	Not reported	Not reported

ECOG Status, 1

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	195

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	41.5	Not reported	Not reported	Not reported	Not reported

ECOG Status, 2

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	195

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	22.6	Not reported	Not reported	Not reported	Not reported

ECOG Status, 3

Analysis denominator · Participants

Group	Source count
Multiple Myeloma (MM) Participants	195

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma (MM) Participants	6.2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
100
denoms
counts
group Id
OG000
value
276
units
Participants
title
Age, Adults (27-90 years)
categories
measurements
group Id
OG000
value
24.1
denoms
counts
group Id
OG000
value
266
units
Participants
title
MM Type, Heavy chain, IgA
categories
measurements
group Id
OG000
value
1.9
denoms
counts
group Id
OG000
value
266
units
Participants
title
MM Type, Heavy chain, IgD
categories
measurements
group Id
OG000
value
56.8
denoms
counts
group Id
OG000
value
266
units
Participants
title
MM Type, Heavy chain, IgG
categories
measurements
group Id
OG000
value
0.8
denoms
counts
group Id
OG000
value
266
units
Participants
title
MM Type, Heavy chain, IgM
categories
measurements
group Id
OG000
value
16.5
denoms
counts
group Id
OG000
value
266
units
Participants
title
MM Type, Heavy chain, No Heavy Chain
categories
measurements
group Id
OG000
value
3.3
denoms
counts
group Id
OG000
value
276
units
Participants
title
MM Type, Light Chain, No Light Chain
categories
measurements
group Id
OG000
value
59.8
denoms
counts
group Id
OG000
value
276
units
Participants
title
MM Type, Light Chain, Kappa
categories
measurements
group Id
OG000
value
37.0
denoms
counts
group Id
OG000
value
276
units
Participants
title
MM Type, Light Chain, Lambda
categories
measurements
group Id
OG000
value
53.6
denoms
counts
group Id
OG000
value
235
units
Participants
title
MM Type, Bence Jones Protein, Yes
categories
measurements
group Id
OG000
value
28.8
denoms
counts
group Id
OG000
value
267
units
Participants
title
ISS Disease Stage I
categories
measurements
group Id
OG000
value
28.1
denoms
counts
group Id
OG000
value
267
units
Participants
title
ISS Disease Stage II

denoms

counts
group Id
OG000
value
276
units
Participants

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).

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 for multiple CRAB signs and cytogenic abnormalities. Percentages were rounded off.

reporting Status

POSTED

time Frame

Day 1

title

Percentage of MM Participants Categorized by Clinical Variables at Diagnosis

type

PRIMARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice