A Study of Real Life Treatment for Multiple Myeloma (MM)

Median Time From the Start of Second Line Therapy of Participants With MM to Second Biochemical Relapse of MM

According to IMWG, biochemical relapse is diagnosed in participants with relapsing MM based on following criteria: increase in serum paraprotein by at least 25% of nadir (absolute increase should be at least \>=0.5 g/L), increase in urine paraprotein by at least 25% (absolute increase of at least \>=200 mg/24 h), more than 25% increase in difference between involved and non-involved FLC with abnormal FLC ratio and absolute increase of at least \>10 mg/dL, increase in plasmacyte infiltration by least \>=10% in participants with non-secretory MM. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line;Therapeutic regimens of 2nd line (Rd, VRD, KRd, IxaRd, DaraRd, EloRd, other).

Time frame: From the start of the second line therapy until second biochemical relapse (up to approximately 4 years)

Median Time From the Start of Second Line Therapy of Participants With MM to Second Symptomatic Relapse of MM

Clinical relapse is confirmed when one or more of the following criteria (CRAB-criteria: MM-associated symptoms, including hypercalcemia, renal failure, anemia, bone disease criteria) are found. Hypercalcemia (\>2.75 mmol/L or \>11.5 mg/dL), renal failure: serum creatinine level \>2 mg/dL (\>173 mmol/L), anemia: normochromic normocytic anemia with hemoglobin level by \<2 g/dL (20 mg/L) less than the lower limit of the normal level or hemoglobin level \<10 g/dL (\<100 g/L), bone lesions (lytic lesions, severe osteopenia, compression fractures). Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line;Therapeutic regimens of 2nd line (Rd, VRD, KRd, IxaRd, DaraRd, EloRd, other).

Time frame: From the start of the second line therapy until second symptomatic relapse (up to approximately 4 years)

PFS1L: Progression-free Survival (PFS) From the Start of first Line Therapy to the First Biochemical Relapse

PFS1L:interval from start of 1st line therapy to 1st significant biochemical relapse. As per IMWG, biochemical relapse diagnosed in participants with relapsing MM on following criteria: increase in serum paraprotein by at least 25% of nadir (absolute increase should be at least \>=0.5 g/L, increase in urine paraprotein by at least 25% (absolute increase of at least \>=200 mg/24 h, \>25% increase in difference between involved and non-involved FLC with abnormal FLC ratio and absolute increase of at least \>10 mg/dL, increase in plasmacyte infiltration by least \>=10% with non-secretory MM. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From the start of the first line therapy until first significant biochemical relapse or until the disease progression or death due to any reason whichever occurs first (up to approximately 4 years)

PFS2L: Progression-free Survival From the Start of Second Line Therapy to the Second Biochemical Relapse

PFS2L: interval from start of 2nd line therapy to 2nd significant biochemical relapse. As per IMWG, biochemical relapse diagnosed in participants with relapsing MM on following criteria: increase in serum paraprotein by at least 25% of nadir (absolute increase should be at least \>=0.5 g/L, increase in urine paraprotein by at least 25% (absolute increase of at least \>=200 mg/24 h, \>25% increase in difference between involved and non-involved FLC with abnormal FLC ratio and absolute increase of at least \>10 mg/dL, increase in plasmacyte infiltration by least \>=10% with non-secretory MM. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line;Therapeutic regimens of 2nd line (Rd, VRD, KRd, IxaRd, DaraRd, EloRd, other).

Time frame: From the start of the second line therapy until second significant biochemical relapse or until the disease progression or death due to any reason whichever occurs first (up to approximately 4 years)

DOT1: Duration of the First Line Therapy

DOT1 is defined as time from initiation of the first drug to discontinuation of the last drug in the frame of first line of therapy. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From initiation of the first drug to discontinuation of the last drug in the frame of first line therapy (approximately 4 years)

DOMT1: Duration of 1st Line Maintenance Therapy

DOMT1 is defined as the treatment duration of first line maintenance therapy. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From initiation of the first line maintenance therapy to discontinuation of the last drug in the frame of first line maintenance therapy (approximately 4 years)

DOT2: Duration of the Second Line Therapy

DOT2 is defined as time from initiation of the first drug to discontinuation of the last drug in the frame of second line of therapy. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line;Therapeutic regimens of 2nd line (Rd, VRD, KRd, IxaRd, DaraRd, EloRd, other).

Time frame: From initiation of the first drug to discontinuation of the last drug in the frame of second line therapy (approximately 4 years)

PR1L: Percentage of Participants With Partial Response After First Line Therapy

PR is defined as \>=50% reduction of serum M protein and \>=90% or \<200 mg reduction urinary M protein in 24-hour, or \>50% decrease in difference between involved and uninvolved FLC levels, or \>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \>30% and \>50% reduction in size of soft tissue plasmacytomas at baseline. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From the end of the first line therapy up to approximately 4 years

VGPR1L: Percentage of Participants With VGPR After First Line Therapy

VGPR defined as \>90% reduction (\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From the end of the first line therapy up to approximately 4 years

CR1L: Percentage of Participants With Complete Response After First Line Therapy

Complete response is defined as \>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line.

Time frame: From the end of the first line therapy up to approximately 4 years

ORR2L: Percentage of Participants With Objective Response Rate After the Second Line Therapy

ORR2L: percentage of participants with CR, VGPR or PR assessed by IMWG to 2nd line therapy. Per IMWG criteria, CR: \>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation; VGPR: \>90% reduction (\<100 mg/24-h) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis; PR: \>=50% reduction of serum M protein and \>=90% or \<200 mg reduction urinary M protein in 24-hour, or \>50% decrease in difference between involved and uninvolved FLC levels, or \>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \>30% and \>50% reduction in size of soft tissue plasmacytomas at baseline. Subgroups for analysis: MM ISS stages: I, II, Ill; MFS: 0 and 1 vs 2 and more;Cytogenetic high-risk vs standard risk; Best response during 1st line treatment;ECOG = 0-1 vs 2, ASCT vs non-ASCT receivers;Maintenance therapy;1st and 2nd line Treatment regimens.

Time frame: From the end of the second line therapy up to approximately 4 years

SD2L: Percentage of Participants With Stable Disease After the Second Line Therapy

Stable disease (SD) is defined as any state that does not meet PR, VGPR, CR, or progressive disease (PD) criteria. Subgroups for analysis: MM ISS stages: I, II, III; MFS: 0 and 1 vs 2 and more;Cytogenetic risk: high-risk vs standard risk; Best response during 1st line treatment: a PR a CR or VGPR; Performance status: ECOG = 0-1 vs ECOG = 2, ASCT vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line;Therapeutic regimens of 2nd line (Rd, VRD, KRd, IxaRd, DaraRd, EloRd, other).

Time frame: From the end of second line therapy up to approximately 4 years

PD2L: Percentage of Participants With Progressive Disease After Second Line Therapy

PD: increase in M-gradient by \>=25% of least achieved serum (increase by \>=5 g/L), urine (increase by \>=200 mg/24 h) levels. With disease, "unmeasurable" by standard immunochemistry, but "measurable" by FLC level, progression: stated with increase in difference between involved and non-involved FLC by 100 mg/L. Progression: increase in bone marrow plasmatic cells level (absolute count-not less than by 10%), occurrence of new bone lesions or increase in size of previously detected ones, occurrence of new soft tissue plasmocytomas or increase in its size, hypercalcemia (corrected serum calcium level \>11.5 mg/dL or 2.65 mmol/L) may be related to proliferation. Subgroups for analysis: MM ISS stages: I, II, Ill; MFS: 0 and 1 vs 2 and more;Cytogenetic high-risk vs standard risk; Best response during 1st line treatment;ECOG = 0-1 vs 2, ASCT vs non-ASCT receivers;Maintenance therapy;1st and 2nd line Treatment regimens.

Time frame: From the end of second line therapy up to approximately 4 years

Percentage of Participants With High-risk Cytogenetic Disorders at the Time of the First Symptomatic Relapse

High-risk Cytogenetic Disorder is defined as risk according to cytogenetic profile at relapse (t\[4;14\], del (17p), amp (1q21), hypodiploidy) at the time of the first symptomatic relapse.

Time frame: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)

Percentage of Participants With High β2-microglobulin (ß2M) or Low Albumin Levels at the Time of the First and Second Symptomatic Relapse

ß2M levels is defined as \>5.5 mg/L and low albumin levels is defined as \<3.5 g/dL at first symptomatic relapse.

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With Extramedullary Lesions at the Time of the First and Second Symptomatic Relapse

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With Lactate Dehydrogenase (LDH) Levels Above Normal at the Time of the First and Second Symptomatic Relapse

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With Short Duration of Response or PD During Therapy at the Time of the First and Second Symptomatic Relapse

PD is defined as increase in M-gradient by \>=25% of least achieved serum (increase by \>=5 g/L), urine (increase by \>=200 mg/24 h) levels. For participants with disease, "unmeasurable" by standard immunochemistry, but "measurable" by FLC level, progression is stated with increase in difference between involved and non-involved FLC by 100 mg/L. Progression is also indicated by increase in bone marrow plasmatic cells level (absolute count - not less than by 10%), occurrence of new bone lesions or increase in size of previously detected ones, occurrence of new soft tissue plasmocytomas or increase in it's size, hypercalcemia (corrected serum calcium level \>11.5 mg/dL or 2.65 mmol/L) that may be related to proliferation. Short duration of response \<6 months.

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With Circulating Plasma Cells at the Time of the First and Second Symptomatic Relapse

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With ISS stages II/III at the Time of the First and Second Symptomatic Relapse

ISS is a measuring scale having three stages Stage I:low risk, β2-Microglobulin \<3.5mg/L and albumin \>=3.5g/dL, Stage II: not stage I or III, Stage III: high risk,β2-Microglobulin \>=5.5mg/L.

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With Isotypic Transformation at the Time of the First and Second Symptomatic Relapse

Isotypic Transformation is defined as change in the type of secretion of light chains, hypersecretory disease.

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Percentage of Participants With First and Second Symptomatic Relapse who Have Aggressive Clinical Disease Manifestations

Aggressive clinical disease manifestations include the rapid development/quick start of symptoms manifestations, an advanced diseases stages based on the laboratory results, radiography or pathomorphological examinations, organ failure (disease-related organ disorder).

Time frame: From the start of the first line therapy until first symptomatic relapse (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)

Number of Participants Reporting One or More Adverse Events (AEs) With First Line Therapy

Time frame: Up to approximately 4 years

Number of Participants Reporting One or More AEs With Second Line Therapy

Time frame: Up to approximately 4 years