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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091127
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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.


Condition or disease
Multiple Myeloma

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).

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Study Type : Observational
Actual Enrollment : 705 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : March 17, 2020
Estimated Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Carfilzomib starting dose [ Time Frame: 18 months ]
    Carfilzomib dose at first administration

  2. Carfilzomib dose [ Time Frame: 18 months ]
    Carfilzomib dose at subsequent administrations

  3. Carfilzomib dose modification [ Time Frame: 18 months ]
    Modification includes change in dose level, dose interruption, and dose delays

  4. Time to carfilzomib dose modification [ Time Frame: 18 months ]
    At least one carfilzomib dose modification, escalation or reduction

  5. Reason for dose modification [ Time Frame: 18 months ]
    Reason for dose modification or delay

  6. Number of cycles started [ Time Frame: 18 months ]
    Number of carfilzomib treatment cycles started throughout study period

  7. Carfilzomib regimen [ Time Frame: 18 months ]
    Treatment combination

  8. Carfilzomib dosing frequency [ Time Frame: 18 months ]
    Number of administrations per cycle

  9. Carfilzomib dosing schedule [ Time Frame: 18 months ]
    Timing of carfilzomib administration within treatment cycle

  10. Carfilzomib duration of treatment [ Time Frame: 18 months ]
    Duration of carfilzomib treatment

  11. Starting dose of concomitant anti-myeloma agents [ Time Frame: 18 months ]
    Dose of combination agents (e.g. lenalidomide or dexamethasone) at baseline

  12. Dose modification for concomitant anti-myeloma agents [ Time Frame: 18 months ]
    Modification includes change in dose level, dose interruption, and dose delays

  13. Reason for frequency modification [ Time Frame: 18 months ]
    At least 1 change in frequency of carfilzomib administration.

  14. Reason for change in frequency of concomitant multiple myeloma therapies [ Time Frame: 18 months ]
    Reason for change in frequency of administration.


Secondary Outcome Measures :
  1. International Staging System (ISS) score and revised ISS stage at diagnosis and carfilzomib regimen initation [ Time Frame: 18 months ]
    International Staging System (ISS) score of I, II, III, or unkown

  2. Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: 18 months ]
    ECOG performance status category at multiple myeloma diagnosis and carfilzomib regimen initiation.

  3. Cytogenetic risk profile at diagnosis [ Time Frame: 18 months ]
    Cytogenetic risk profile at diagnosis

  4. Presence of CRAB features (i.e. hypercalcemia, renal insufficiency, anemia and/or bone pain) [ Time Frame: 18 months ]
    Presence of CRAB features at MM diagnosis

  5. Presence of comorbidities [ Time Frame: 18 months ]
    Diagnosed at any point in time before carflzomib regimen initiation

  6. Previously received anti-myeloma treatment [ Time Frame: 18 months ]
    Treatment history

  7. Response to prior treatment [ Time Frame: 18 months ]
    Response to prior treatment received before initiation of carfilzomib

  8. Number of prior relapses [ Time Frame: 18 months ]
    Type of relapse (molecular, hematologic, or symptomatic)

  9. Adverse event [ Time Frame: 18 months ]
    All grade 3 or above adverse events.

  10. Time to adverse event [ Time Frame: 18 months ]
    All grade 3 or above adverse events

  11. Electrocardiogram (ECG) changes [ Time Frame: 18 months ]
    ECG changes as recorded in tests performed per routine practice

  12. Decrease in left ventricular ejection fraction (LVEF) [ Time Frame: 18 months ]
    LVEF decrease as recorded in tests performed per routine practice

  13. Initiation or dose increase of antihypertensive treatment [ Time Frame: 18 months ]
    Initiation or dose increase of existing antihypertensive treatment

  14. Initiation or dose increase of existing heart failure treatment [ Time Frame: 18 months ]
    Initiation or dose increase of existing heart failure treatment

  15. Response to carfilzomib treatment [ Time Frame: 18 months ]
    Physician-assessed response as recorded on the medical charts

  16. Type of relapse [ Time Frame: 18 months ]
    Molecular, hematologic or symptomatic relapse

  17. Number of unplanned hospitalisations [ Time Frame: 18 months ]
    Initiation or dose increase of existing heart failure treatment

  18. Concomitant therapy not part of the carfilzomib regimen [ Time Frame: 18 months ]
    Concomitant therapy not part of the carfilzomib regimen

  19. Planned subsequent treatment regimen [ Time Frame: 18 months ]
    Planned subsequent treatment regimen catergory

  20. Patient age [ Time Frame: 18 months ]
    Patient age

  21. Patient sex [ Time Frame: 18 months ]
    Patient sex

  22. Patient height [ Time Frame: 18 months ]
    Patient height

  23. Patient weight [ Time Frame: 18 months ]
    Patient weight

  24. MRI (magnetic resonance imaging) performed at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    MRI (magnetic resonance imaging)

  25. PET-CT (positron emission tomography-computed tomography) performed at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    PET-CT (positron emission tomography-computed tomography)

  26. Measurement of Serum M component at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Serum M component

  27. Measurement of Urine M component at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Urine M component

  28. Measurement of serum albumin at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Serum albumin

  29. Measurement of serum beta-2-microglobulin at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Beta-2-microglobulin

  30. Measurement of percent of plasma cells in bone marrow at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Percent of plasma cells in bone marrow

  31. Baseline measurement of lactate dehydrogenase at MM diagnosis and carfilzomib regimen initiation. [ Time Frame: 18 months ]
    Lactate dehydrogenase

  32. ECG (electrocardiogram) [ Time Frame: 18 months ]
    ECG (electrocardiogram)

  33. Echocardiogram [ Time Frame: 18 months ]
    Echocardiogram

  34. LVEF (left ventricular ejection fraction) assessment [ Time Frame: 18 months ]
    LVEF (left ventricular ejection fraction) assessment

  35. Computed Tomography (CT) performed at MM diagnosis and carfilzomib regiment initiation. [ Time Frame: 18 Months ]
    Computed tomography

  36. Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation [ Time Frame: 18 months ]
    Myeloma/Osteolytic lesions detected by MRI, PET-CT, and X-ray at MM diagnosis and carfilzomib regimen initiation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Multiple Myeloma
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091127


Locations
Show Show 112 study locations
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03091127    
Other Study ID Numbers: 20150262
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases