Multiple MyelomaLEADERNCT04985643
A Study of Real Life Treatment for Multiple Myeloma (MM)
An observational study of Multiple Myeloma, run by Takeda at 24 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 357 participants
- Where
- 24 sitesRussia
- Study dates
- 18 Feb 2022to 20 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll participants who have a confirmed diagnosis of MM in clinical sites located in the Russian Federation.
Who may be able to join
- With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.
Who cannot join
- With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion.
- Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Russia24 sites
Altai Regional Clinical Hospital
Barnaul, Altayskiy Kray, 656024
BaltikMed Clinic
Kaliningrad, Northwestern Federal District, 238022
Kaluga Regional Clinical Hospital
Kaluga, Central Federal District, 248007
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', Republic Tatarstan, 420064
City Clinical Hospital No. 1 named after prof. S.I.Sergeev
Khabarovsk, Far Eastern Federal District, 680009
District Clinical Hospital
Khanty-Mansiysk, Tyumen Oblast, 628012
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, Kirov Oblast, 610027
GUZ "Lipetsk City Hospital No. 3" Free Falcon "
Lipetsk, Lipetsk Oblast, 398007
National Research Center of Hematology of the Ministry of Health
Moscow, Moscow Oblast, 125167
Herzen Moscow Scientific Research Oncological Institute
Moscow, Moscow Oblast, 125284
Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
Moscow, Moscow Oblast, 129110
City Clinical Hospital No. 12
Nizhny Novgorod, Volga Federal District, 603003
Novosibirsk State Medical University, Department of Therapy, Hematology and Transfusiology based on City Clinical Hospital No. 2
Novosibirsk, Novosibirsk Oblast, 630051
Orenburgskaya Regional Clinical Hospital n.a. V.I. Voinova
Orenburg, Orenburgskaya District, 460018
Republican hospital named after V.A.Baranov
Petrozavodsk, Republic of Karelia, 185019
City Clinical Hospital No. 31
Saint Petersburg, Sankt-Peterburg, 197110
Razumovskiy Saratov State Medical University, University Clinical
Saratov, Saratov Oblast, 410028
Smolensk Clinical Hospital of Russian Railways-Medicine
Smolensk, Central Federal District, 214025
Surgut Regional Clinical Hospital
Surgut, Tyumen Oblast, 628408
Tomsk Regional Clinical Hospital
Tomsk, Siberian Federal District, 634063
Republican Clinical Hospital named after G.G. Kuvatov
Ufa, 450005
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Ulyanovsk Oblast, 432017
Clinic Akademicheskaya LLC
Volgograd, Volgogradskaya District, 400001
Vologda Regional Clinical Hospital
Vologda, Northwestern Federal District, 160002
About this study
Official title: Local, Multicentre, Non-Interventional Study of Early Diagnostics of Multiple Myeloma Relapses Evaluation in Real Life Practice in the Russian Federation
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.
Read the detailed description
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:
- Participants With MM
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.
- Conditions
- Multiple Myeloma
- Keywords
- Drug Therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With MM | Participants diagnosed with MM (complete response [CR], very good partial response [VGPR] and partial response [PR]) and who have received one prior first line treatment within 3 months preceding the enrollment, will be observed retrospectively and medical data will be monitored and collected prospectively every 3 months until the second biochemical and symptomatic relapse is identified. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM
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.
Measured: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
Secondary outcomes (26)
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM in the Determined Subgroups
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
Measured: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
Median Time From the Start of First Line Therapy of Participants With MM
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.
Measured: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Up to approximately 4 years
Number of Participants Reporting One or More AEs With Second Line Therapy
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start18 Feb 2022
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985643
- Sponsor's protocol ID
- C16058
- Acronym
- LEADER
- Status last verified
- May 2026
- First submitted
- 29 Jul 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local, Multicentre, Non-Interventional Study of Early Diagnostics of Multiple Myeloma Relapses Evaluation in Real Life Practice in the Russian Federation
- ClinicalTrials.gov ID
- NCT04985643
- Acronym / sponsor ID
- LEADER / C16058
- Conditions
- Multiple Myeloma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 357 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Participants With MM
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With MM | – | –Participants diagnosed with MM (complete response [CR], very good partial response [VGPR] and partial response [PR]) and who have received one prior first line treatment within 3 months preceding the enrollment, will be observed retrospectively and medical data will be monitored and collected prospectively every 3 months until the second biochemical and symptomatic relapse is identified. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll participants who have a confirmed diagnosis of MM in clinical sites located in the Russian Federation.
Key inclusion criteria (2 listed)
- With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.
Key exclusion criteria (2 listed)
- With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion.
- Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM
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.
26 secondary outcomes
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM in the Determined Subgroups
Time frame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
Median Time From the Start of First Line Therapy of Participants With MM
Time frame: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
Median Time From the Start of Second Line Therapy of Participants With MM to Second Biochemical Relapse of MM
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Takeda at 24 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM (time frame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.