Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe

Amgen705 enrolled

Overview

With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.

With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. The Primary Objective is to describe carfilzomib utilisation in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation. * Secondary Objectives: * Describe the population treated with carfilzomib in terms of demographics, multiple myeloma (MM) disease characteristics, treatment history, and comorbidities. * Describe the safety profile of carfilzomib in routine clinical practice. * Describe response to treatment as assessed by the physician and recorded in the medical file. * Describe healthcare resource utilisation of subjects treated with carfilzomib, in terms of unplanned hospitalisations. * Describe the reasons for choosing carfilzomib as the MM treatment of choice. * Describe specific concomitant therapy (bisphosphonates, thromboprophylaxis, antihypertensive treatment, anti-infective treatment) and whether these therapies were used as prophylaxis or as treatment. * Describe a cardiovascular assessment at carfilzomib regimen initiation and at occurrence of cardiac adverse events, where available per routine care (electrocardiogram \[ECG\], echocardiography, left ventricular ejection fraction).

Study Type

OBSERVATIONAL

Enrollment

705

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older at the time of carfilzomib initiation * At least one prior line of MM treatment has been received * Carfilzomib treatment has been initiated per routine practice and is currently ongoing * At least one administration of carfilzomib in a combination regimen (ie, not monotherapy) has been received * Provided written informed consent prior to abstraction of any data, in countries where written informed consent is required. * Subjects who previously completed treatment with carfilzomib in a clinical trial, a compassionate use program or through routine practice, are eligible to take part in the study. * Subjects who receive radiotherapy concurrently with carfilzomib treatment are also eligible to take part in the study. * Subjects who initiate carfilzomib treatment on a combination regimen, subsequently discontinue all concomitant medications but remain on carfilzomib monotherapy in later cycles, remain eligible for participation in the study. * Subjects who are also enrolled in other observational studies in which standard of care is not altered are eligible to take part in the study, Exclusion Criteria: * Subjects who are enrolled in a carfilzomib clinical trial will not be eligible to additionally take part in this observational study. * Subjects who are receiving carfilzomib treatment within a compassionate use program will not be eligible to take part in this observational study. If a subject who has enrolled into this observational study, also enrolls in a clinical trial in which MM treatment and/or disease management is protocol-specified, the subject becomes ineligible and the subject's data will be censored from the time the subject enrolled the clinical trial.

Locations (114)

Outcomes

Primary Outcomes

Carfilzomib starting dose

Carfilzomib dose at first administration

Time frame: 18 months

Carfilzomib dose

Carfilzomib dose at subsequent administrations

Time frame: 18 months

Carfilzomib dose modification

Modification includes change in dose level, dose interruption, and dose delays

Time frame: 18 months

Time to carfilzomib dose modification

At least one carfilzomib dose modification, escalation or reduction

Time frame: 18 months

Reason for dose modification

Reason for dose modification or delay

Time frame: 18 months

Number of cycles started

Number of carfilzomib treatment cycles started throughout study period

Time frame: 18 months

Carfilzomib regimen

Treatment combination

Time frame: 18 months

Carfilzomib dosing frequency

Number of administrations per cycle

Time frame: 18 months

Carfilzomib dosing schedule

Timing of carfilzomib administration within treatment cycle

Time frame: 18 months

Carfilzomib duration of treatment

Data from ClinicalTrials.gov

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Krankenhaus Sankt Josef Braunau

Braunau am Inn, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Landeskrankenhaus Hochsteiermark

Leoben, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Landeskrankenhaus Rankweil

Rankweil, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Kardinal Schwarzenbergsches Krankenhaus

Schwarzach im Pongau, Austria

Landeskrankenhaus Steyr

Steyr, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria

Landesklinikum Waidhofen an der Ybbs

Waidhofen an der Ybbs, Austria

...and 104 more locations

Secondary Outcomes

International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation

International Staging System (ISS) score of I, II, III, or unkown

Time frame: 18 months

Eastern Cooperative Oncology Group (ECOG) performance status

ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.

Time frame: 18 months

Cytogenetic risk profile at diagnosis

Time frame: 18 months

Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)

Presence of CRAB features at MM diagnosis

Time frame: 18 months

Presence of comorbidities

Diagnosed at any point in time before carflzomib regimen initiation

Time frame: 18 months

Previously received anti-myeloma treatment

Treatment history

Time frame: 18 months

Response to prior treatment

Response to prior treatment received before initiation of carfilzomib

Time frame: 18 months

Number of prior relapses

Type of relapse (molecular, hematologic, or symptomatic)

Time frame: 18 months

Adverse event

All grade 3 or above adverse events.

Time frame: 18 months

Time to adverse event

All grade 3 or above adverse events

Time frame: 18 months

Electrocardiogram (ECG) changes

ECG changes as recorded in tests performed per routine practice

Time frame: 18 months

Decrease in left ventricular ejection fraction (LVEF)

LVEF decrease as recorded in tests performed per routine practice

Time frame: 18 months

Initiation or dose increase of antihypertensive treatment

Initiation or dose increase of existing antihypertensive treatment

Time frame: 18 months

Initiation or dose increase of existing heart failure treatment

Time frame: 18 months

Response to carfilzomib treatment

Physician-assessed response as recorded on the medical charts

Time frame: 18 months

Type of relapse

Molecular, hematologic or symptomatic relapse

Time frame: 18 months

Number of unplanned hospitalisations

Initiation or dose increase of existing heart failure treatment

Time frame: 18 months

Concomitant therapy not part of the carfilzomib regimen

Time frame: 18 months

Planned subsequent treatment regimen

Planned subsequent treatment regimen catergory

Time frame: 18 months

Patient age

Time frame: 18 months

Patient sex

Time frame: 18 months

Patient height

Time frame: 18 months

Patient weight

Time frame: 18 months

MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.

MRI (magnetic resonance imaging)

Time frame: 18 months

PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.

PET-CT (positron emission tomography-computed tomography)

Time frame: 18 months

Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.

Serum M component

Time frame: 18 months

Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.

Urine M component

Time frame: 18 months

Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.

Serum albumin

Time frame: 18 months

Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.

Beta-2-microglobulin

Time frame: 18 months

Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.

Percent of plasma cells in bone marrow

Time frame: 18 months

Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.

Lactate dehydrogenase

Time frame: 18 months

ECG (electrocardiogram)

Time frame: 18 months

Echocardiogram

Time frame: 18 months

LVEF (left ventricular ejection fraction) assessment

Time frame: 18 months

Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.

Computed tomography

Time frame: 18 Months

Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation

Time frame: 18 months