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NCT03506386 · OUTCOME

Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics

Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis · Source last updated 2021-02-08

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]

What was measured

MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories.

Analysis population: All participants eligible for analyses were included. Number analyzed are the participants with data available for analyses of the specific category.

Groups in this outcome

Multiple Myeloma Participants

Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), 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 Participants	943

Reported measurements

Bone Marrow Biopsy: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	342	Not reported	Not reported	Not reported	Not reported

Bone Marrow Biopsy: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	366	Not reported	Not reported	Not reported	Not reported

Bone Marrow Aspiration: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	48	Not reported	Not reported	Not reported	Not reported

Bone Marrow Aspiration: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	36	Not reported	Not reported	Not reported	Not reported

Bone or Extramedullary Biopsy: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	232	Not reported	Not reported	Not reported	Not reported

Bone or Extramedullary Biopsy: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	241	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: Yes: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	161	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: Yes: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	142	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: No: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	245	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: No: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	281	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: Unknown: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	46	Not reported	Not reported	Not reported	Not reported

Immunohistochemistry Performed: Unknown: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	68	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: Yes: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	136	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: Yes: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	130	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: No: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	254	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: No: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	293	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: Unknown: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	62	Not reported	Not reported	Not reported	Not reported

Flow Cytometry Performed: Unknown: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	942

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	67	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Bone Lesion: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	15	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Bone Lesion: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	35	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Anemia: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	354	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Anemia: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	342	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Hypercalcemia: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	286	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Hypercalcemia: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	343	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Renal failure: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	70	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: Renal failure: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	74	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition:Serum Involved/Uninvolved Free Light Chain Ratio of >=100:Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	80	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition:Serum Involved/Uninvolved Free Light Chain Ratio of >=100:Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	125	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: >1 Focal Lesion on MRI That is >=5mm in Size: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	4	Not reported	Not reported	Not reported	Not reported

MM Diagnosis Definition: >1 Focal Lesion on MRI That is >=5mm in Size: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	17	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	31	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	34	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG Kappa: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	138	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG Kappa: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	152	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG Lambda: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	47	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgG Lambda: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	55	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	18	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	17	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA Kappa: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	40	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA Kappa: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	37	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA Lambda: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	32	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgA Lambda: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	24	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Kappa Only: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	38	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Kappa Only: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	42	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Lambda Only: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	32	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Lambda Only: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	22	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgE: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	1	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgE: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	0	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgM: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	2	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: IgM: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	2	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Non-secretory: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	18	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Non-secretory: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	10	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Unknown: Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	55	Not reported	Not reported	Not reported	Not reported

Monoclonal Component: Unknown: Not Eligible

Analysis denominator · Participants

Group	Source count
Multiple Myeloma Participants	943

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Multiple Myeloma Participants	96	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
342
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone Marrow Biopsy: Eligible
categories
measurements
group Id
OG000
value
366
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone Marrow Biopsy: Not Eligible
categories
measurements
group Id
OG000
value
48
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone Marrow Aspiration: Eligible
categories
measurements
group Id
OG000
value
36
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone Marrow Aspiration: Not Eligible
categories
measurements
group Id
OG000
value
232
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone or Extramedullary Biopsy: Eligible
categories
measurements
group Id
OG000
value
241
denoms
counts
group Id
OG000
value
943
units
Participants
title
Bone or Extramedullary Biopsy: Not Eligible
categories
measurements
group Id
OG000
value
161
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: Yes: Eligible
categories
measurements
group Id
OG000
value
142
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: Yes: Not Eligible
categories
measurements
group Id
OG000
value
245
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: No: Eligible
categories
measurements
group Id
OG000
value
281
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: No: Not Eligible
categories
measurements
group Id
OG000
value
46
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: Unknown: Eligible
categories
measurements
group Id
OG000
value
68
denoms
counts
group Id
OG000
value
943
units
Participants
title
Immunohistochemistry Performed: Unknown: Not Eligible

denoms

counts
group Id
OG000
value
943
units
Participants

description

MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories.

groups

description
Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.
id
OG000
title
Multiple Myeloma Participants

param Type

COUNT_OF_PARTICIPANTS

population Description

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

reporting Status

POSTED

time Frame

From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]

title

Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice