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Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone or in Combination With Darzalex® and Dexamethasone in Multiple Myeloma Patients (CARO)

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ClinicalTrials.gov Identifier: NCT02970747
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
The objective of this non-interventional study (NIS) is to evaluate patients' adherence and persistence to carfilzomib therapy in combination with lenalidomide and dexamethasone or in combination with dexamethasone alone or in combination with daratumumab and dexamethasone in adult patients with multiple myeloma (MM) who have received at least one prior therapy in a real-life setting.

Condition or disease Intervention/treatment
Multiple Myeloma in Relapse Drug: Carfilzomib

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional Study of Carfilzomib (Kyprolis®) in Combination With Lenalidomide (Revlimid®) and Dexamethasone or Carfilzomib in Combination With Dexamethasone Alone or Carfilzomib in Combination With Daratumumab (Darzalex®) and Dexamethasone in Patients With Multiple Myeloma Who Have Received at Least One Prior Therapy
Actual Study Start Date : October 25, 2016
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Carfilzomib

Group/Cohort Intervention/treatment
Car/Len/Dex (KRd)
Patients treated with carfilzomib, lenalidomide and dexamethasone dosage form, dosage, frequency and duration of treatment according to current SmPC
Drug: Carfilzomib
In accordance with SmPC.
Other Name: Kyprolis®

Car/Dex (Kd)
Patients treated with carfilzomib and dexamethasone dosage form, dosage, frequency and duration of treatment according to current SmPC
Drug: Carfilzomib
In accordance with SmPC.
Other Name: Kyprolis®

Car/Dex/Dara (KdD)
Patients treated with carfilzomib, dexamethasone and daratumumab dosage form, dosage, frequency and duration of treatment according to current SmPC
Drug: Carfilzomib
In accordance with SmPC.
Other Name: Kyprolis®




Primary Outcome Measures :
  1. Patients' adherence and persistence to carfilzomib therapy [ Time Frame: Duration of Carfilzomib therapy, up to 24 months after last patient in ]
    Patients' adherence and persistence to carfilzomib therapy


Secondary Outcome Measures :
  1. Patients' adherence and persistence to lenalidomide, dexamethasone and daratumumab therapy [ Time Frame: Duration of Carfilzomib therapy, up to 24 months after last patient in ]
    Patients' adherence and persistence to lenalidomide, dexamethasone and daratumumab therapy


Other Outcome Measures:
  1. Median Progression-free Survival (PFS) [ Time Frame: 93 months ]
    Median Progression-free Survival (PFS)

  2. Overall Survival (OS) rate at 24 months [ Time Frame: 24 months ]
    Overall Survival (OS) rate at 24 months

  3. Median Time to Response (TTR) [ Time Frame: 93 months ]
    Median Time to Response (TTR)

  4. Median Duration of Response (DOR) [ Time Frame: 93 months ]
    Median Duration of Response (DOR)

  5. Overall Response Rate (ORR) [ Time Frame: 93 months ]
    ORR is defined as ≥ Very Good Partial Response (VGPR) + Partial Response (PR)

  6. To assess safety and tolerability measured by adverse events as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4.03 [ Time Frame: Duration of Carfilzomib therapy (+ 30 days), up to 25 months after last patient in ]
    AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.

  7. To assess health-related QoL using the validated BOMET-QoL-10 questionnaire [ Time Frame: Baseline, 6, 12, 18, 24, End of Treatment (latest 93 months) ]
    QoL data will be collected at baseline, after 6, 12, 18, 24 months (during treatment) and at the end of Carfilzomib therapy



Information from the National Library of Medicine

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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
Adult patients with multiple myeloma (MM) who have received at least one prior therapy
Criteria

Inclusion Criteria:

  • Aged 18 years or older.
  • Patients with MM who have received at least one prior therapy.
  • Indication for treatment as assessed by the treating physician.
  • Decision for second- or subsequent-line treatment with the combination therapy carfilzomib/ lenalidomide/ dexamethasone or carfilzomib/ dexamethasone or carfilzomib/ dexamethasone/ daratumumab
  • Signed written informed consent.
  • Criteria according to the current Summary of Product Characteristics (SmPC) for Kyprolis® (Carfilzomib)

Exclusion Criteria:

  • Contraindications according to the current SmPC for Kyprolis® (Carfilzomib)

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): NCT02970747


Contacts
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Contact: Anita Schuch, Dr. + 49 761 15242 ext 0 information@iomedico.com

Locations
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Germany
Centrum für Hämatologie und Onkologie Bethanien Recruiting
Frankfurt, Germany, 60389
Contact: Wolfgang Knauf, Professor         
Sponsors and Collaborators
iOMEDICO AG
Amgen
Investigators
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Principal Investigator: Wolfgang Knauf, Professor Centrum für Hämatologie und Onkologie Bethanien, Germany, 60389 Frankfurt a.M.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT02970747    
Other Study ID Numbers: IOM-070337
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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