NCT02970747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

8.5 years

First QC Date

November 10, 2016

Last Update Submit

November 20, 2025

Conditions

Multiple Myeloma in Relapse

Outcome Measures

Primary Outcomes (1)

  • Patients' adherence and persistence to carfilzomib therapy

    Patients' adherence and persistence to carfilzomib therapy

    Duration of Carfilzomib therapy, up to 24 months after last patient in

Secondary Outcomes (1)

  • Patients' adherence and persistence to lenalidomide, dexamethasone and daratumumab therapy

    Duration of Carfilzomib therapy, up to 24 months after last patient in

Other Outcomes (7)

  • Median Progression-free Survival (PFS)

    up to 24 months after last patient in

  • Overall Survival (OS) rate at 24 months

    24 months

  • Median Time to Response (TTR)

    up to 24 months after last patient in

  • +4 more other outcomes

Study Arms (3)

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

Car/Dex (Kd)

Patients treated with carfilzomib and dexamethasone dosage form, dosage, frequency and duration of treatment according to current SmPC

Drug: Carfilzomib

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

Interventions

CarfilzomibDRUG

In accordance with SmPC.

Also known as: Kyprolis®
Car/Dex (Kd)Car/Dex/Dara (KdD)Car/Len/Dex (KRd)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, 60389, Germany

Location

Related Publications (1)

  • Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.

    PMID: 33218965DERIVED

MeSH Terms

Interventions

carfilzomib

Study Officials

  • Wolfgang Knauf, Professor

    Centrum für Hämatologie und Onkologie Bethanien, Germany, 60389 Frankfurt a.M.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 22, 2016

Study Start

October 25, 2016

Primary Completion

April 26, 2025

Study Completion

April 26, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)