Trial Outcomes & Findings for Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis (NCT NCT03506386)
NCT ID: NCT03506386
Last Updated: 2021-02-08
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
943 participants
Primary outcome timeframe
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]
Results posted on
2021-02-08
Participant Flow
Participants took part in the study at 17 investigative sites in Brazil from 9 August 2018 to 27 January 2020.
Participants with a diagnosis of Multiple Myeloma (MM) were observed to collect data retrospectively between eligibility window: 1 January 2008 to 31 December 2016, in this study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
943
|
|
Overall Study
COMPLETED
|
943
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis
Baseline characteristics by cohort
| Measure |
Multiple Myeloma Participants
n=943 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.
|
|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
437 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
506 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
576 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Pardo (Mixed Race or Mulatto)
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indigenous Person
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
157 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
943 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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]Population: All participants eligible for analyses were included. Number analyzed are the participants with data available for analyses of the specific category.
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.
Outcome measures
| Measure |
Multiple Myeloma Participants
n=943 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.
|
|---|---|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone Marrow Biopsy: Eligible
|
342 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone Marrow Biopsy: Not Eligible
|
366 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone Marrow Aspiration: Eligible
|
48 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone Marrow Aspiration: Not Eligible
|
36 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone or Extramedullary Biopsy: Eligible
|
232 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Bone or Extramedullary Biopsy: Not Eligible
|
241 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: Yes: Eligible
|
161 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: Yes: Not Eligible
|
142 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: No: Eligible
|
245 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: No: Not Eligible
|
281 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: Unknown: Eligible
|
46 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Immunohistochemistry Performed: Unknown: Not Eligible
|
68 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: Yes: Eligible
|
136 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: Yes: Not Eligible
|
130 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: No: Eligible
|
254 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: No: Not Eligible
|
293 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: Unknown: Eligible
|
62 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Flow Cytometry Performed: Unknown: Not Eligible
|
67 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Bone Lesion: Eligible
|
15 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Bone Lesion: Not Eligible
|
35 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Anemia: Eligible
|
354 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Anemia: Not Eligible
|
342 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Hypercalcemia: Eligible
|
286 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Hypercalcemia: Not Eligible
|
343 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Renal failure: Eligible
|
70 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: Renal failure: Not Eligible
|
74 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition:Serum Involved/Uninvolved Free Light Chain Ratio of >=100:Eligible
|
80 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition:Serum Involved/Uninvolved Free Light Chain Ratio of >=100:Not Eligible
|
125 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: >1 Focal Lesion on MRI That is >=5mm in Size: Eligible
|
4 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
MM Diagnosis Definition: >1 Focal Lesion on MRI That is >=5mm in Size: Not Eligible
|
17 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG: Eligible
|
31 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG: Not Eligible
|
34 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG Kappa: Eligible
|
138 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG Kappa: Not Eligible
|
152 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG Lambda: Eligible
|
47 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgG Lambda: Not Eligible
|
55 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA: Eligible
|
18 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA: Not Eligible
|
17 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA Kappa: Eligible
|
40 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA Kappa: Not Eligible
|
37 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA Lambda: Eligible
|
32 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgA Lambda: Not Eligible
|
24 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Kappa Only: Eligible
|
38 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Kappa Only: Not Eligible
|
42 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Lambda Only: Eligible
|
32 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Lambda Only: Not Eligible
|
22 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgE: Eligible
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgE: Not Eligible
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgM: Eligible
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: IgM: Not Eligible
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Non-secretory: Eligible
|
18 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Non-secretory: Not Eligible
|
10 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Unknown: Eligible
|
55 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
Monoclonal Component: Unknown: Not Eligible
|
96 Participants
|
PRIMARY outcome
Timeframe: 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]Population: All participants eligible for analyses were included. Number analyzed are the number of participants with evaluable data for given category.
Treatment patterns were collected from institutional charts \[included public institution, private institution and both (90% public and 10% private) institutions\] of participants in Brazil. The treatment patterns were collected as induction treatment, consolidation treatment, maintenance treatment performed at Baseline (at initial diagnosis) and as a induction treatment, maintenance treatment and type of treatment performed after transplantation, for second to tenth line of treatment. Only categories with data are reported. Participants were counted multiple times in different categories.
Outcome measures
| Measure |
Multiple Myeloma Participants
n=922 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.
|
|---|---|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Induction Treatment Performed · Public Institution
|
394 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Induction Treatment Performed · Private Institution
|
456 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
66 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Consolidation Treatment Performed · Public Institution
|
3 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Consolidation Treatment Performed · Private Institution
|
14 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Consolidation Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Maintenance Treatment Performed · Public Institution
|
39 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Maintenance Treatment Performed · Private Institution
|
32 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
Baseline: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
5 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Induction Treatment Performed · Public Institution
|
230 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Induction Treatment Performed · Private Institution
|
236 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
29 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Maintenance Treatment Performed · Public Institution
|
22 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Maintenance Treatment Performed · Private Institution
|
9 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
4 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Type of Treatment Performed After Transplantation · Public Institution
|
7 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Type of Treatment Performed After Transplantation · Private Institution
|
6 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
2nd Line: Type of Treatment Performed After Transplantation · Both (90% public and 10% private) Institutions
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Induction Treatment Performed · Public Institution
|
142 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Induction Treatment Performed · Private Institution
|
131 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
11 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Maintenance Treatment Performed · Public Institution
|
13 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Maintenance Treatment Performed · Private Institution
|
3 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Type of Treatment Performed After Transplantation · Public Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Type of Treatment Performed After Transplantation · Private Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
3rd Line: Type of Treatment Performed After Transplantation · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Induction Treatment Performed · Public Institution
|
70 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Induction Treatment Performed · Private Institution
|
70 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
6 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Maintenance Treatment Performed · Public Institution
|
3 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Maintenance Treatment Performed · Private Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Type of Treatment Performed After Transplantation · Public Institution
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Type of Treatment Performed After Transplantation · Private Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
4th Line: Type of Treatment Performed After Transplantation · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Induction Treatment Performed · Public Institution
|
38 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Induction Treatment Performed · Private Institution
|
37 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
3 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th line: Maintenance Treatment Performed · Public Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th line: Maintenance Treatment Performed · Private Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th line: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Type of Treatment Performed After Transplantation · Public Institution
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Type of Treatment Performed After Transplantation · Private Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
5th Line: Type of Treatment Performed After Transplantation · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Induction Treatment Performed · Public Institution
|
21 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Induction Treatment Performed · Private Institution
|
19 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Maintenance Treatment Performed · Public Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Maintenance Treatment Performed · Private Institution
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
6th Line: Maintenance Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
7th Line: Induction Treatment Performed · Public Institution
|
6 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
7th Line: Induction Treatment Performed · Private Institution
|
10 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
7th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
8th Line: Induction Treatment Performed · Public Institution
|
3 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
8th Line: Induction Treatment Performed · Private Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
8th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
9th Line: Induction Treatment Performed · Public Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
9th Line: Induction Treatment Performed · Private Institution
|
2 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
9th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
10th Line: Induction Treatment Performed · Public Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
10th Line: Induction Treatment Performed · Private Institution
|
1 Participants
|
|
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
10th Line: Induction Treatment Performed · Both (90% public and 10% private) Institutions
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of diagnosis up to death within the period of interest (between January 1, 2008, and December 31, 2016) or up to the end of this study [up to 11.7 years]Population: All participants eligible for analyses who had non-missing observations were analyzed. Number analyzed is the number of participants with data available for given category.
Overall survival was defined as the time elapsed between the date of diagnosis until death, with censoring of participants who were alive when last seen or who lost to follow up.
Outcome measures
| Measure |
Multiple Myeloma Participants
n=922 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.
|
|---|---|
|
Overall Survival (OS)
Eligible for Transplantation but not Performed
|
1926 days
Interval 1516.0 to 2834.0
|
|
Overall Survival (OS)
Eligible for Transplantation and Performed
|
3277 days
Interval 2859.0 to
The upper limit of 95% confidence interval were not estimable due to low number of participants with data.
|
|
Overall Survival (OS)
Not Eligible for Transplantation
|
1566 days
Interval 1367.0 to 1894.0
|
SECONDARY outcome
Timeframe: From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first up to the end of this study (up to 11.7 years)Population: All participants eligible for analyses who had non-missing observations were analyzed. Number analyzed is the number of participants with data available for given category.
Duration of treatment was defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who lost to follow-up before discontinuation. Duration of treatment was classified by participants eligibility- eligible/not eligible for transplantation. The deaths occurred after treatment initiation to end of study are reported in categories 'Since Diagnosis to Death-Eligible and Not Eligible'.
Outcome measures
| Measure |
Multiple Myeloma Participants
n=922 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.
|
|---|---|
|
Duration of Treatment
Since Diagnosis for Living Participants: Eligible
|
5 years
Interval 0.6 to 11.7
|
|
Duration of Treatment
Since Diagnosis for Living Participants: Not Eligible
|
4.2 years
Interval 0.0 to 11.2
|
|
Duration of Treatment
Since Diagnosis to Lost to Follow-up: Eligible
|
3.6 years
Interval 0.0 to 8.5
|
|
Duration of Treatment
Since Diagnosis to Lost to Follow-up: Not Eligible
|
2.3 years
Interval 0.1 to 8.6
|
|
Duration of Treatment
Since Diagnosis to Death: Eligible
|
2.8 years
Interval 0.0 to 9.9
|
|
Duration of Treatment
Since Diagnosis to Death: Not Eligible
|
1.8 years
Interval 0.0 to 10.0
|
Adverse Events
Multiple Myeloma Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 436 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER