Clinical trial NCT04985643: A Study of Real Life Treatment for Multiple Myeloma (MM)
Official title: Local, Multicentre, Non-Interventional Study of Early Diagnostics of Multiple Myeloma Relapses Evaluation in Real Life Practice in the Russian Federation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll participants who have a confirmed diagnosis of MM in clinical sites located in the Russian Federation.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.

Exclusion Criteria:

1. 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.
2. Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.

Primary outcomes:
measure: Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM
timeFrame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
Secondary outcomes:
measure: Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM in the Determined Subgroups
timeFrame: From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
measure: Median Time From the Start of First Line Therapy of Participants With MM
timeFrame: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
measure: Median Time From the Start of Second Line Therapy of Participants With MM to Second Biochemical Relapse of MM
timeFrame: From the start of the second line therapy until second biochemical relapse (up to approximately 4 years)
measure: Median Time From the Start of Second Line Therapy of Participants With MM to Second Symptomatic Relapse of MM
timeFrame: From the start of the second line therapy until second symptomatic relapse (up to approximately 4 years)
measure: PFS1L: Progression-free Survival (PFS) From the Start of first Line Therapy to the First Biochemical Relapse
timeFrame: 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)
measure: PFS2L: Progression-free Survival From the Start of Second Line Therapy to the Second Biochemical Relapse
timeFrame: 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)
measure: DOT1: Duration of the First Line Therapy
timeFrame: From initiation of the first drug to discontinuation of the last drug in the frame of first line therapy (approximately 4 years)
measure: DOMT1: Duration of 1st Line Maintenance Therapy
timeFrame: 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)
measure: DOT2: Duration of the Second Line Therapy
timeFrame: From initiation of the first drug to discontinuation of the last drug in the frame of second line therapy (approximately 4 years)
measure: PR1L: Percentage of Participants With Partial Response After First Line Therapy
timeFrame: From the end of the first line therapy up to approximately 4 years
measure: VGPR1L: Percentage of Participants With VGPR After First Line Therapy
timeFrame: From the end of the first line therapy up to approximately 4 years
measure: CR1L: Percentage of Participants With Complete Response After First Line Therapy
timeFrame: From the end of the first line therapy up to approximately 4 years
measure: ORR2L: Percentage of Participants With Objective Response Rate After the Second Line Therapy
timeFrame: From the end of the second line therapy up to approximately 4 years
measure: SD2L: Percentage of Participants With Stable Disease After the Second Line Therapy
timeFrame: From the end of second line therapy up to approximately 4 years
measure: PD2L: Percentage of Participants With Progressive Disease After Second Line Therapy
timeFrame: From the end of second line therapy up to approximately 4 years
measure: Percentage of Participants With High-risk Cytogenetic Disorders at the Time of the First Symptomatic Relapse
timeFrame: From the start of the first line therapy until first symptomatic relapse (up to approximately 4 years)
measure: Percentage of Participants With High β2-microglobulin (ß2M) or Low Albumin Levels at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With Extramedullary Lesions at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With Lactate Dehydrogenase (LDH) Levels Above Normal at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With Short Duration of Response or PD During Therapy at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With Circulating Plasma Cells at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With ISS stages II/III at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With Isotypic Transformation at the Time of the First and Second Symptomatic Relapse
timeFrame: 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)
measure: Percentage of Participants With First and Second Symptomatic Relapse who Have Aggressive Clinical Disease Manifestations
timeFrame: 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)
measure: Number of Participants Reporting One or More Adverse Events (AEs) With First Line Therapy
timeFrame: Up to approximately 4 years
measure: Number of Participants Reporting One or More AEs With Second Line Therapy
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Altai Regional Clinical Hospital
state: Altay Region
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Hospital
state: Central Federal District
city: Smolensk
country: Russian Federation
facility: Smolensk Clinical Hospital of Russian Railways-Medicine
state: Central Federal District
city: Khabarovsk
country: Russian Federation
facility: City Clinical Hospital No. 1 named after prof. S.I.Sergeev
state: Far Eastern Federal District
city: Kirov
country: Russian Federation
facility: Kirov Research Institute of Hematology and Blood Transfusion
state: Kirov Region
city: Lipetsk
country: Russian Federation
facility: GUZ "Lipetsk City Hospital No. 3" Free Falcon "
state: Lipetsk Region
city: Moscow
country: Russian Federation
facility: National Research Center of Hematology of the Ministry of Health
state: Moscow Region
city: Moscow
country: Russian Federation
facility: Herzen Moscow Scientific Research Oncological Institute
state: Moscow Region
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky
state: Moscow Region
city: Kaliningrad
country: Russian Federation
facility: BaltikMed Clinic
state: Northwestern Federal District
city: Vologda
country: Russian Federation
facility: Vologda Regional Clinical Hospital
state: Northwestern Federal District
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University, Department of Therapy, Hematology and Transfusiology based on City Clinical Hospital No. 2
state: Novosibirsk Region
city: Orenburg
country: Russian Federation
facility: Orenburgskaya Regional Clinical Hospital n.a. V.I. Voinova
state: Orenburgskaya District
city: Petrozavodsk
country: Russian Federation
facility: Republican hospital named after V.A.Baranov
state: Republic Of Karelia
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
state: Republic Tatarstan
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital No. 31
state: Saint Petersburg
city: Saratov
country: Russian Federation
facility: Razumovskiy Saratov State Medical University, University Clinical
state: Saratov Region
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
state: Siberian Federal District
city: Khanty-Mansiysk
country: Russian Federation
facility: District Clinical Hospital
state: Tyumen Region
city: Surgut
country: Russian Federation
facility: Surgut Regional Clinical Hospital
state: Tyumen Region
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
state: Ulyanovsk Region
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital No. 12
state: Volga Federal District
city: Volgograd
country: Russian Federation
facility: Clinic Akademicheskaya LLC
state: Volgogradskaya District
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital named after G.G. Kuvatov
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: