Multiple MyelomaSEATTLENCT05954780
Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma
An observational study of Multiple Myeloma, run by iOMEDICO AG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Selinexor
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jun 2023to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- Contraindications according to selinexor SmPC for patients with MM
- Participation in an interventional clinical trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
Vienna, 1090
Germany1 site
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Ravensburg, Baden-Wurttemberg, 88212
About this study
Official title: A Non-interventional Study of Selinexor (Nexpovio®) in Combination With Bortezomib and Dexamethasone (SVd) in Patients With Relapsed or Refractory Multiple Myeloma (R/RMM)
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Selinexor
- Keywords
- Multiple Myeloma, Selinexor, Bortezomib, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC
| Study group | Role | What they receive |
|---|---|---|
| second line and later lines therapy | Patients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone. Receives: Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of EORTC global health scale
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.
Measured: Baseline, up to 40 months
Secondary outcomes (41)
Change from baseline of EORTC QLQ-C30 further scales
Change from baseline in further scales of the EORTC QLQ-C30 questionnaire
Measured: Baseline, up to 40 months
Change from baseline of EORTC QLQ-MY20 further scales
Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire
Measured: Baseline, up to 30 days after selinexor treatment
Assessment of drug tolerability and safety
Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue)
Measured: Baseline, up to 40 months
Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.
Measured: Baseline, up to 30 days after end of selinexor treatment
Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)
Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.
Measured: Baseline, up to 30 days after end of selinexor treatment
Adverse events of special interest (AESI)
Incidence of AEs of special interest defined as cataracts (new-onset cataracts and worsening of cataracts) and Acute cerebellar syndrome.
Measured: Baseline, up to 30 days after end of selinexor treatment
Changes in selinexor therapy
Frequency of treatment delays, no administrations (skips), discontinuation (withdrawn) of selinexor due to safety reasons
Measured: From date of selinexor treatment start, up to 40 months
Effectiveness in routine treatment: Best response
Frequencies of best response during selinexor therapy will be calculated using descriptive statistics.
Measured: Baseline, up to 40 months
Effectiveness in routine treatment: Overall response rate (ORR)
ORR of patients will be calculated. ORR is defined as the proportion of patients achieving a complete response, very good partial response or partial response as best overall response. Patients without response measurement are considered non-responders.
Measured: Baseline, up to 40 months
Effectiveness in routine treatment: Disease control rate (DCR)
DCR is defined as the proportion of patients achieving complete response, very good partial response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders.
Measured: Baseline, up to 40 months
Effectiveness in routine treatment: Progression-free survival (PFS)
PFS is defined as the time interval measured from the day of first selinexor administration to first progression or death, whichever comes first.
Measured: Baseline, up to 40 months
6 months PFS rate
PFS rates will be analysed 6 months after treatment start of selinexor
Measured: Baseline, until 6 months after start of selinexor treatment
12 months PFS rate
PFS rates will be analysed 12 months after treatment start of selinexor
Measured: Baseline, until 12 months after start of selinexor treatment
Effectiveness in routine treatment: Overall survival (OS)
OS is defined as the time interval measured from the day of first selinexor administration to time of death from any cause.
Measured: Baseline, up to 40 months
6 months OS rate
OS rates will be analysed 6 and 12 months after treatment start of selinexor
Measured: Baseline, until 6 months after start of selinexor treatment
12 months OS rate
OS rates will be analysed 6 and 12 months after treatment start of selinexor
Measured: Baseline, until 12 months after start of selinexor treatment
Selinexor therapy: Dosing
Dose intensity during treatment (mg/m2 per week) will be analysed
Measured: Baseline, up to end of selinexor treatment
Selinexor therapy: Frequency
Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed
Measured: Cycle 1, day 1
Selinexor therapy: Dose reduction of starting dose
Reasons for reduced starting dose compared to SmPC will be analysed
Measured: Cycle 1, day 1
Selinexor therapy: Dose changes
Reasons for dose reductions and dose re-escalation during treatment compared to previous dose
Measured: From date of second selinexor application, up to 40 months
Previous therapies
Frequency of distinct previous therapies (systemic / radiation / transplantation)
Measured: Baseline
Daratumumab-based previous therapies
Frequency of patients with daratumumab-based previous therapies
Measured: Baseline
Treatment duration
Treatment duration of selinexor therapy
Measured: From date of selinexor treatment start, up to 40 months
Subsequent antineoplastic therapies
Frequency of distinct subsequent antineoplastic therapies.
Measured: From Date of end of selinexor treatment up to 40 months
Subsequent antineoplastic transplantations
Frequency of distinct subsequent antineoplastic transplantations.
Measured: From Date of end of selinexor treatment up to 40 months
Subsequent antineoplastic radiations
Frequency of distinct subsequent antineoplastic radiations.
Measured: From Date of end of selinexor treatment up to 40 months
Frequency of concomitant medication
Frequency of concomitant medication administered
Measured: Baseline up to 30 days after end of selinexor therapy
Anti-emetic substances for AE treatment
Use of anti-emetic substances for AE treatment
Measured: Baseline up to 30 days after end of selinexor treatment
Anti-emetic substances for prophylaxis
Use of anti-emetic substances for prophlaxis
Measured: From date of selinexor treatment start, up to 40 months
Anti-diarrhea substances for AE treatment
Use of anti-diarrhea substances for AE treatment
Measured: Baseline up to 30 days after end of selinexor treatment
Anti-diarrhea substances for prophylaxis
Use of anti-diarrhea substances for prophylaxis
Measured: From date of selinexor treatment start, up to 40 months
Anti-emetic and anti-diarrhea substances for AE treatment
Use of anti-emetic and anti-diarrhea substances for AE treatment
Measured: From date of selinexor treatment start, up to date of end of selinexor treatment
Anti-emetic and anti-diarrhea substances for prophylaxis
Use of anti-emetic and anti-diarrhea substances for prophylaxis
Measured: From date of selinexor treatment start, up to date of end of selinexor treatment
Administration of Glucocorticoids and NK1 antagonist for prophylaxis
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 antagonist administration used for prophylaxis.
Measured: From date of selinexor treatment start, up to 40 months
Administration of NK1 + 5HT3 antagonist for prophylaxis
Frequency of NK1 + 5HT3 antagonist administration used for prophylaxis
Measured: From date of selinexor treatment start, up to 40 months
Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + 5HT3 antagonist administration used for prophylaxis.
Measured: From date of selinexor treatment start, up to 40 months
Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 + 5HT3 antagonist administration used for prophylaxis.
Measured: From date of selinexor treatment start, up to 40 months
Therapy decision
Assessment of parameters of therapy decision making.
Measured: Baseline
Therapy choice
Frequency of distinct parameters affecting therapy choice.
Measured: Baseline
Assessment of myeloma comorbidity index R-MCI
Assessment of R-MCI in all patients and patients with different starting doses
Measured: Baseline
R-MCI risk groups
Frequency of R-MCI risk groups in all patients and according to different selinexor starting dosages (100 mg vs. 80 mg vs. 60 mg).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start28 Jun 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Menarini Group, Climedo Health GmbH
- Responsible party
- Sponsor
- Investigators
- Tobias Dechow, Prof. Dr., Study chair, Gemeinschaftspraxis für Hämatologie und Onkologie GbRMaria Krauth, Assoc. Prof. PD Dr., Study chair, Universitätsklinikum AKH Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954780
- Sponsor's protocol ID
- IOM-090494
- Acronym
- SEATTLE
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Selinexor (Nexpovio®) in Combination With Bortezomib and Dexamethasone (SVd) in Patients With Relapsed or Refractory Multiple Myeloma (R/RMM)
- ClinicalTrials.gov ID
- NCT05954780
- Acronym / sponsor ID
- SEATTLE / IOM-090494
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Selinexor, Bortezomib, Dexamethasone
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Menarini Group, Climedo Health GmbH
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| second line and later lines therapy | – | Drug: SelinexorPatients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications according to selinexor SmPC for patients with MM
- Participation in an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorSelinexor/bortezomib/dexamethasone according to Nexpovio® SmPC | Drug | second line and later lines therapy |
Primary outcome
Change from baseline of EORTC global health scale
Time frame: Baseline, up to 40 months
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.
41 secondary outcomes
Change from baseline of EORTC QLQ-C30 further scales
Time frame: Baseline, up to 40 months
Change from baseline of EORTC QLQ-MY20 further scales
Time frame: Baseline, up to 30 days after selinexor treatment
Assessment of drug tolerability and safety
Time frame: Baseline, up to 40 months
Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
Time frame: Baseline, up to 30 days after end of selinexor treatment
Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)
Time frame: Baseline, up to 30 days after end of selinexor treatment
Adverse events of special interest (AESI)
Time frame: Baseline, up to 30 days after end of selinexor treatment
Changes in selinexor therapy
Time frame: From date of selinexor treatment start, up to 40 months
Effectiveness in routine treatment: Best response
Time frame: Baseline, up to 40 months
Effectiveness in routine treatment: Overall response rate (ORR)
Time frame: Baseline, up to 40 months
Effectiveness in routine treatment: Disease control rate (DCR)
Time frame: Baseline, up to 40 months
Effectiveness in routine treatment: Progression-free survival (PFS)
Time frame: Baseline, up to 40 months
6 months PFS rate
Time frame: Baseline, until 6 months after start of selinexor treatment
12 months PFS rate
Time frame: Baseline, until 12 months after start of selinexor treatment
Effectiveness in routine treatment: Overall survival (OS)
Time frame: Baseline, up to 40 months
6 months OS rate
Time frame: Baseline, until 6 months after start of selinexor treatment
12 months OS rate
Time frame: Baseline, until 12 months after start of selinexor treatment
Selinexor therapy: Dosing
Time frame: Baseline, up to end of selinexor treatment
Selinexor therapy: Frequency
Time frame: Cycle 1, day 1
Selinexor therapy: Dose reduction of starting dose
Time frame: Cycle 1, day 1
Selinexor therapy: Dose changes
Time frame: From date of second selinexor application, up to 40 months
Previous therapies
Time frame: Baseline
Daratumumab-based previous therapies
Time frame: Baseline
Treatment duration
Time frame: From date of selinexor treatment start, up to 40 months
Subsequent antineoplastic therapies
Time frame: From Date of end of selinexor treatment up to 40 months
Subsequent antineoplastic transplantations
Time frame: From Date of end of selinexor treatment up to 40 months
Subsequent antineoplastic radiations
Time frame: From Date of end of selinexor treatment up to 40 months
Frequency of concomitant medication
Time frame: Baseline up to 30 days after end of selinexor therapy
Anti-emetic substances for AE treatment
Time frame: Baseline up to 30 days after end of selinexor treatment
Anti-emetic substances for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Anti-diarrhea substances for AE treatment
Time frame: Baseline up to 30 days after end of selinexor treatment
Anti-diarrhea substances for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Anti-emetic and anti-diarrhea substances for AE treatment
Time frame: From date of selinexor treatment start, up to date of end of selinexor treatment
Anti-emetic and anti-diarrhea substances for prophylaxis
Time frame: From date of selinexor treatment start, up to date of end of selinexor treatment
Administration of Glucocorticoids and NK1 antagonist for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Administration of NK1 + 5HT3 antagonist for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis
Time frame: From date of selinexor treatment start, up to 40 months
Therapy decision
Time frame: Baseline
Therapy choice
Time frame: Baseline
Assessment of myeloma comorbidity index R-MCI
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Dechow, Prof. Dr. study chair
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Maria Krauth, Assoc. Prof. PD Dr. study chair
Universitätsklinikum AKH Wien
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by iOMEDICO AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of EORTC global health scale (time frame: Baseline, up to 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.