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

Conditions

Multiple Myeloma

Brief summary

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.

Detailed description

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).

Evangelos Terpos, Borhane Slama, Renato Zambello, Sorina Bădeliță, Eirini Katodritou et al. (11 authors)

Blood2020-11-055 citations

10.1182/blood-2020-134475

Real-World Evidence of the Use of Approved Carfilzomib Regimens in Patients Previously Exposed or Refractory to Lenalidomide: Updated Results from a Prospective Observational Study

Xavier Leleu, Borhane Slama, Renato Zambello, Sorina Bădeliță, Eirini Katodritou et al. (11 authors)

Blood2020-11-05

10.1182/blood-2020-134476

Real-World Evidence of the Use of Carfilzomib and Dexamethasone (Kd) By Lenalidomide-Refractory Status: An Interim Analysis from a Prospective Observational Study

Xavier Leleu, Jo Caers, Barbara Gamberi, Maaike Söhne, Sonja Heibl et al. (9 authors)

Blood2019-11-13

10.1182/blood-2019-122938

PF616 REAL‐WORLD USE OF THE TRIPLET REGIMEN CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (KRD) IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA: A SUB‐GROUP INTERIM ANALYSIS FROM A PROSPECTIVE OBSERVATIONAL STUDY

Xavier Leleu, Barbara Gamberi, Jo Caers, Sonja Heibl, Maaike Söhne et al. (10 authors)

HemaSphere2019-06-011 citations

10.1097/01.hs9.0000560752.69224.f7

Real-world use of carfilzomib among multiple myeloma patients with at least one prior therapy.

Evangelos Terpos, Barbara Gamberi, Jo Caers, Maaike Söhne, Sonja Heibl et al. (10 authors)

Journal of Clinical Oncology2019-05-203 citations

10.1200/jco.2019.37.15_suppl.e19515

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Carfilzomib starting dose	18 months	Carfilzomib dose at first administration
Carfilzomib dose	18 months	Carfilzomib dose at subsequent administrations
Carfilzomib dose modification	18 months	Modification includes change in dose level, dose interruption, and dose delays
Time to carfilzomib dose modification	18 months	At least one carfilzomib dose modification, escalation or reduction
Reason for dose modification	18 months	Reason for dose modification or delay
Number of cycles started	18 months	Number of carfilzomib treatment cycles started throughout study period
Carfilzomib regimen	18 months	Treatment combination
Carfilzomib dosing frequency	18 months	Number of administrations per cycle
Carfilzomib dosing schedule	18 months	Timing of carfilzomib administration within treatment cycle
Carfilzomib duration of treatment	18 months	Duration of carfilzomib treatment
Starting dose of concomitant anti-myeloma agents	18 months	Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline
Dose modification for concomitant anti-myeloma agents	18 months	Modification includes change in dose level, dose interruption, and dose delays
Reason for frequency modification	18 months	At least 1 change in frequency of carfilzomib administration.
Reason for change in frequency of concomitant multiple myeloma therapies	18 months	Reason for change in frequency of administration.

Secondary

Measure	Time frame	Description
Response to carfilzomib treatment	18 months	Physician-assessed response as recorded on the medical charts
Type of relapse	18 months	Molecular, hematologic or symptomatic relapse
Number of unplanned hospitalisations	18 months	Initiation or dose increase of existing heart failure treatment
Concomitant therapy not part of the carfilzomib regimen	18 months	Concomitant therapy not part of the carfilzomib regimen
Planned subsequent treatment regimen	18 months	Planned subsequent treatment regimen catergory
Patient age	18 months	Patient age
Patient sex	18 months	Patient sex
Patient height	18 months	Patient height
Patient weight	18 months	Patient weight
MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation.	18 months	MRI (magnetic resonance imaging)
PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation.	18 months	PET-CT (positron emission tomography-computed tomography)
Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation.	18 months	Serum M component
Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation.	18 months	Urine M component
Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation.	18 months	Serum albumin
Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation.	18 months	Beta-2-microglobulin
Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation.	18 months	Percent of plasma cells in bone marrow
Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation.	18 months	Lactate dehydrogenase
Number of prior relapses	18 months	Type of relapse (molecular, hematologic, or symptomatic)
Echocardiogram	18 months	Echocardiogram
LVEF (left ventricular ejection fraction) assessment	18 months	LVEF (left ventricular ejection fraction) assessment
Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation.	18 Months	Computed tomography
Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation	18 months	Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation
ECG (electrocardiogram)	18 months	ECG (electrocardiogram)
International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation	18 months	International Staging System (ISS) score of I, II, III, or unkown
Eastern Cooperative Oncology Group (ECOG) performance status	18 months	ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.
Cytogenetic risk profile at diagnosis	18 months	Cytogenetic risk profile at diagnosis
Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain)	18 months	Presence of CRAB features at MM diagnosis
Presence of comorbidities	18 months	Diagnosed at any point in time before carflzomib regimen initiation
Previously received anti-myeloma treatment	18 months	Treatment history
Response to prior treatment	18 months	Response to prior treatment received before initiation of carfilzomib
Adverse event	18 months	All grade 3 or above adverse events.
Time to adverse event	18 months	All grade 3 or above adverse events
Electrocardiogram (ECG) changes	18 months	ECG changes as recorded in tests performed per routine practice
Decrease in left ventricular ejection fraction (LVEF)	18 months	LVEF decrease as recorded in tests performed per routine practice
Initiation or dose increase of antihypertensive treatment	18 months	Initiation or dose increase of existing antihypertensive treatment
Initiation or dose increase of existing heart failure treatment	18 months	Initiation or dose increase of existing heart failure treatment

Countries

Austria, Belgium, Bulgaria, Czechia, France, Greece, Israel, Italy, Netherlands, Norway, Romania

Outcome results