NCT Number: NCT04985643
The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study.
Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Altai Regional Clinical Hospital, Barnaul, Altayskiy Kray, Russia
This is a non-interventional, prospective study of participants with MM relapses. This study will assess the low detection rate of biochemical relapses which will improve routine clinical practices and management of participants with MM in real world practice.
The study will enroll approximately 350 participants. The data will be collected both prospectively and/or retrospectively at the specialized care (hematology) and will be recorded into electronic case report forms (e-CRFs) of the electronic data capture (EDC) system. All the participants will be assigned to a single observational cohort:
This multi-center study will be conducted in the Russian Federation. The overall duration of the study will be approximately 4 years. The overall time for treatment and follow-up period will be approximately 2.5 years for each participant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
According to the International Myeloma Working Group (IMWG), biochemical relapse is diagnosed in participants with relapsing MM based on the following criteria: increase in serum paraprotein by at least 25 percent (%) of nadir (absolute increase should be at least greater than or equal to [>=] 0.5 gram per liter [g/L]), increase in urine paraprotein by at least 25% (absolute increase of at least >=200 milligram per 24 hours [mg/24 h]), more than 25% increase in the difference between involved and non-involved free light chains (FLC) with abnormal FLC ratio and absolute increase of at least greater than (>) 10 milligram per deciliter (mg/dL), increase in plasmacyte infiltration by least >=10% in participants with non-secretory MM.
Time frame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
As per IMWG, biochemical relapse diagnosed 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 International Staging System (ISS) stages: I, II, III; Myeloma frailty score (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: Eastern Cooperative Oncology Group (ECOG) = 0-1 vs ECOG = 2;Autologous Stem Cell Transplant (ASCT) vs non-ASCT receivers; Maintenance therapy; Treatment regimens of 1st line
Time frame: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
Clinical relapse is confirmed when one or more of the following criteria (CRAB-criteria: MM-associated symptoms: hypercalcemia, renal failure, anemia, bone disease criteria). Hypercalcemia (>2.75 millimole per liter [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 less than (<) 2 g/dL (20 milligram per liter [mg/L]) less than the lower limit of the normal level or hemoglobin level <10 g/dL (<100 gram per liter [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 CR8 or VGPR9; 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 second line therapy until second biochemical relapse (up to approximately 4 years)
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 symptomatic relapse (up to approximately 4 years)
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 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)
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 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)
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 initiation of the first drug to discontinuation of the last drug in the frame of first line therapy (approximately 4 years)
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 line maintenance therapy to discontinuation of the last drug in the frame of first line maintenance therapy (approximately 4 years)
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 drug to discontinuation of the last drug in the frame of second line therapy (approximately 4 years)
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 the end of the first line therapy up to approximately 4 years
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
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
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 second line therapy up to approximately 4 years
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 second line therapy up to approximately 4 years
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
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 start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
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 (for first symptomatic relapse) and until second symptomatic relapse (for second symptomatic relapse) (up to approximately 4 years)
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)
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)
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)
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)
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)
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)
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)
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: Up to approximately 4 years
Time frame: Up to approximately 4 years
Takeda
Industry
Local, Multicentre, Non-Interventional Study of Early Diagnostics of Multiple Myeloma Relapses Evaluation in Real Life Practice in the Russian Federation
Acronym: LEADER
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