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Trial Title:
Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT05954780
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Selinexor
Bortezomib
Dexamethasone
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC
Arm group label:
second line and later lines therapy
Summary:
The non-interventional study SEATTLE aims to answer open scientific questions regarding
QoL and tolerability/safety and AE management of selinexor as well as effectiveness and
dosing in clinical routine. Thus, SEATTLE will provide real-world evidence complementary
to pivotal studies.
Detailed description:
Multiple myeloma (MM) accounts for approximately 10% of hematological malignancies. Since
MM patients are elderly and often comorbid patients, risk-adapted treatment strategies to
further improve outcome in is crucial.Selinexor, a potent, oral, SINE (selective
inhibitors of nuclear exports) binds reversibly to XPO. This leads to nuclear
localization and functional activation of tumor suppressor proteins, which further leads
to suppression of nuclear factor κB activity, and reduction in oncoprotein mRNA
translation. All this induces apoptosis of tumor cells. Since treatment options for MM
are various and the most important factor is to keep or improve quality of life (QoL) of
the patients, there is an urge for real-world clinical data of MM patients treated with
selinexor in clinical routine. The objective of this non-interventional study is to
evaluate QoL and tolerability/safety and AE management as well as effectiveness and
dosing in adult patients with relapsed or refractory MM, which receive selinexor in
combination with bortezomib and dexamethasone in the 2nd or later therapy line in a
real-world setting.
Criteria for eligibility:
Study pop:
Adult patients (≥18 years old) with relapsed or refractory multiple myeloma and decision
for treatment with selinexor in combination with bortezomib and dexamethasone (SVd) in
≥2nd therapy line
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Relapsed or refractory multiple myeloma
- Indication and decision for ≥2nd-line treatment with selinexor in combination with
bortezomib and dexamethasone according to current selinexor SmPC as assessed by the
treating physician
- Treatment decision before inclusion into this non-interventional study
- Willingness and ability to participate in the electronic patient-reported outcome
(ePRO) module and answering of questionnaires
- Age ≥18 years
- Signed and dated informed consent form
- Inclusion before start of treatment (prospective inclusion)
Exclusion Criteria:
- Contraindications according to selinexor SmPC for patients with MM
- Participation in an interventional clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Maria Krauth, Assoc. Prof. PD Dr.
Phone:
+43 1 40400 - 44100
Email:
maria.krauth@meduniwien.ac.at
Facility:
Name:
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Address:
City:
Ravensburg
Zip:
88212
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Tobias Dechow, Prof. Dr.
Phone:
+49 751 366197-0
Email:
info@onkonet.eu
Start date:
June 28, 2023
Completion date:
September 15, 2026
Lead sponsor:
Agency:
iOMEDICO AG
Agency class:
Industry
Collaborator:
Agency:
Stemline Switzerland GmbH
Agency class:
Other
Collaborator:
Agency:
Climedo Health GmbH
Agency class:
Other
Source:
iOMEDICO AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954780
