Description of the management and outcomes of patients with frontline transplant-eligible multiple myeloma in four European countries (France, Germany, Spain and Italy)

Real-world study of the management and outcomes of patients with frontline transplant-eligible multiple myeloma in four European countries (France, Germany, Spain and Italy)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN88858357

Enrollment

400

Registered

2021-11-22

Start date

2020-01-01

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontline transplant-eligible multiple myeloma Cancer Multiple myeloma

Interventions

A non-interventional retrospective observational study will be conducted in France, Germany, Italy and Spain. Patients with a reported diagnosis of multiple myeloma (MM) and on ongoing active treatmen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study population 1 (ongoing FLTE MM population): 1. Being on an ongoing frontline therapy line 2. Being considered either fit for transplant at initial diagnosis, or planned on transplant while on frontline therapy, or having already been transplanted while on frontline therapy Study population 2 (previous FLTE MM population): 1. Being on an ongoing relapse or refractory multiple myeloma therapy line 2. Having received a previous frontline therapy line 3. Being considered either fit for transplant at initial diagnosis, or having already been transplanted while on frontline therapy

Exclusion criteria

Exclusion criteria: Study population 1 (ongoing FLTE MM population): 1. Receiving the ongoing frontline therapy as part of a randomized controlled trial or early access program Study population 2 (previous FLTE MM population): 1. Having initiated the frontline induction prior to 2017

Design outcomes

Primary

Measure	Time frame
Repartition of the treatments received by the patients with frontline transplant eligible multiple myeloma in induction, consolidation, and maintenance phases and evolution of the repartition by year from 2017 to 2019, extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection.	—

Measure

Time frame

Repartition of the treatments received by the patients with frontline transplant eligible multiple myeloma in induction, consolidation, and maintenance phases and evolution of the repartition by year from 2017 to 2019, extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection.

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Secondary

Measure	Time frame
1. Time from frontline induction to frontline stem cell transplantation extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from start of frontline induction to frontline stem cell transplantation. 2. Time to next treatment calculated as the duration from the date of initiation of first-line induction to the initiation of the second line of treatment extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from start of frontline induction to initiation of second line of treatment. 3. Best observed response defined as per standard International myeloma working group response criteria over each previous phase of treatment extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 4. Time to best-observed response calculated as the duration from the date of initiation of frontline therapy to the most recent best-observed response date extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 5. Duration of therapy calculated as the time from the start of a given treatment to the discontinuation of the same treatment for any reason extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 6. Treatment-free interval calculated as the time from the discontinuation of first-line the	—

Measure

Time frame

1. Time from frontline induction to frontline stem cell transplantation extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from start of frontline induction to frontline stem cell transplantation. 2. Time to next treatment calculated as the duration from the date of initiation of first-line induction to the initiation of the second line of treatment extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from start of frontline induction to initiation of second line of treatment. 3. Best observed response defined as per standard International myeloma working group response criteria over each previous phase of treatment extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 4. Time to best-observed response calculated as the duration from the date of initiation of frontline therapy to the most recent best-observed response date extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 5. Duration of therapy calculated as the time from the start of a given treatment to the discontinuation of the same treatment for any reason extracted from the Cancerology MM database editions of those four countries (French 2020 & 2021, German 2021, Spanish 2020, and Italian 2020 editions) collected for the period from diagnosis to date of data collection. 6. Treatment-free interval calculated as the time from the discontinuation of first-line the

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Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026