Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma - SEATTLE-

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05954780

Studienbeginn:
Juni 2023

Letztes Update:
20.07.2023

Wirkstoff:
Selinexor

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
Stemline Switzerland GmbH, Climedo Health GmbH,

Studienleiter

Tobias Dechow, Prof. Dr.
Study Chair
Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Maria Krauth, Assoc. Prof. PD Dr.
Study Chair
Universitätsklinikum AKH Wien

Kontakt

Daniel Kummer, Dr.
Kontakt:
Phone: +49761-152420
E-Mail: seattle@iomedico.com» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Gemeinschaftspraxis für Hämatologie und Onkologie GbR
88212 Ravensburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tobias Dechow, Prof. Dr.
Phone: +49 751 366197-0
E-Mail: info@onkonet.eu» Ansprechpartner anzeigen

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
1090 Wien
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Maria Krauth, Assoc. Prof. PD Dr.
Phone: +43 1 40400 - 44100
E-Mail: maria.krauth@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change from baseline of EORTC global health scale (Time Frame - Baseline, up to 28 months):
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.

Secondary outcome:

1. Change from baseline of EORTC QLQ-C30 further scales (Time Frame - Baseline, up to 28 months):
Change from baseline in further scales of the EORTC QLQ-C30 questionnaire

2. Change from baseline of EORTC QLQ-MY20 further scales (Time Frame - Baseline, up to 30 days after selinexor treatment):
Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire

3. Assessment of drug tolerability and safety (Time Frame - Baseline, up to 28 months):
Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue)

4. Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE (Time Frame - Baseline, up to 30 days after end of selinexor treatment):
Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.

5. Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) (Time Frame - Baseline, up to 30 days after end of selinexor treatment):
Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.

6. Adverse events of special interest (AESI) (Time Frame - Baseline, up to 30 days after end of selinexor treatment):
Incidence of AEs of special interest defined as cataracts (new-onset cataracts and worsening of cataracts) and Acute cerebellar syndrome.

7. Changes in selinexor therapy (Time Frame - From date of selinexor treatment start, up to 28 months):
Frequency of treatment delays, no administrations (skips), discontinuation (withdrawn) of selinexor due to safety reasons

8. Effectiveness in routine treatment: Best response (Time Frame - Baseline, up to 28 months):
Frequencies of best response during selinexor therapy will be calculated using descriptive statistics.

9. Effectiveness in routine treatment: Overall response rate (ORR) (Time Frame - Baseline, up to 28 months):
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.

10. Effectiveness in routine treatment: Disease control rate (DCR) (Time Frame - Baseline, up to 28 months):
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.

11. Effectiveness in routine treatment: Progression-free survival (PFS) (Time Frame - Baseline, up to 28 months):
PFS is defined as the time interval measured from the day of first selinexor administration to first progression or death, whichever comes first.

12. 6 months PFS rate (Time Frame - Baseline, until 6 months after start of selinexor treatment):
PFS rates will be analysed 6 months after treatment start of selinexor

13. 12 months PFS rate (Time Frame - Baseline, until 12 months after start of selinexor treatment):
PFS rates will be analysed 12 months after treatment start of selinexor

14. Effectiveness in routine treatment: Overall survival (OS) (Time Frame - Baseline, up to 28 months):
OS is defined as the time interval measured from the day of first selinexor administration to time of death from any cause.

15. 6 months OS rate (Time Frame - Baseline, until 6 months after start of selinexor treatment):
OS rates will be analysed 6 and 12 months after treatment start of selinexor

16. 12 months OS rate (Time Frame - Baseline, until 12 months after start of selinexor treatment):
OS rates will be analysed 6 and 12 months after treatment start of selinexor

17. Selinexor therapy: Dosing (Time Frame - Baseline, up to end of selinexor treatment):
Dose intensity during treatment (mg/m2 per week) will be analysed

18. Selinexor therapy: Frequency (Time Frame - Cycle 1, day 1):
Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed

19. Selinexor therapy: Dose reduction of starting dose (Time Frame - Cycle 1, day 1):
Reasons for reduced starting dose compared to SmPC will be analysed

20. Selinexor therapy: Dose changes (Time Frame - From date of second selinexor application, up to 28 months):
Reasons for dose reductions and dose re-escalation during treatment compared to previous dose

21. Previous therapies (Time Frame - Baseline):
Frequency of distinct previous therapies (systemic / radiation / transplantation)

22. Daratumumab-based previous therapies (Time Frame - Baseline):
Frequency of patients with daratumumab-based previous therapies

23. Treatment duration (Time Frame - From date of selinexor treatment start, up to 28 months):
Treatment duration of selinexor therapy

24. Subsequent antineoplastic therapies (Time Frame - From Date of end of selinexor treatment up to 28 months):
Frequency of distinct subsequent antineoplastic therapies.

25. Subsequent antineoplastic transplantations (Time Frame - From Date of end of selinexor treatment up to 28 months):
Frequency of distinct subsequent antineoplastic transplantations.

26. Subsequent antineoplastic radiations (Time Frame - From Date of end of selinexor treatment up to 28 months):
Frequency of distinct subsequent antineoplastic radiations.

27. Frequency of concomitant medication (Time Frame - Baseline up to 30 days after end of selinexor therapy):
Frequency of concomitant medication administered

28. Anti-emetic substances for AE treatment (Time Frame - Baseline up to 30 days after end of selinexor treatment):
Use of anti-emetic substances for AE treatment

29. Anti-emetic substances for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Use of anti-emetic substances for prophlaxis

30. Anti-diarrhea substances for AE treatment (Time Frame - Baseline up to 30 days after end of selinexor treatment):
Use of anti-diarrhea substances for AE treatment

31. Anti-diarrhea substances for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Use of anti-diarrhea substances for prophylaxis

32. 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):
Use of anti-emetic and anti-diarrhea substances for AE treatment

33. Anti-emetic and anti-diarrhea substances for prophylaxis (Time Frame - From date of selinexor treatment start, up to date of end of selinexor treatment):
Use of anti-emetic and anti-diarrhea substances for prophylaxis

34. Administration of Glucocorticoids and NK1 antagonist for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 antagonist administration used for prophylaxis.

35. Administration of NK1 + 5HT3 antagonist for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Frequency of NK1 + 5HT3 antagonist administration used for prophylaxis

36. Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + 5HT3 antagonist administration used for prophylaxis.

37. Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis (Time Frame - From date of selinexor treatment start, up to 28 months):
Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 + 5HT3 antagonist administration used for prophylaxis.

38. Therapy decision (Time Frame - Baseline):
Assessment of parameters of therapy decision making.

39. Therapy choice (Time Frame - Baseline):
Frequency of distinct parameters affecting therapy choice.

40. Assessment of myeloma comorbidity index R-MCI (Time Frame - Baseline):
Assessment of R-MCI in all patients and patients with different starting doses

41. R-MCI risk groups (Time Frame - Baseline):
Frequency of R-MCI risk groups in all patients and according to different selinexor starting dosages (100 mg vs. 80 mg vs. 60 mg).

Geprüfte Regime

Selinexor:
Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Quelle: ClinicalTrials.gov

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