Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03589222
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2018-06-12
Brief Title:
SELIBORDARA Selinexor Bortezomib and Daratumumab in Multiple Myeloma
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
An Open-label Multicenter Phase 2 Trial of Selinexor KPT-330 Bortezomib and Low-dose Dexamethasone Plus Daratumumab SELIBORDARA for the Treatment of Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 single-arm open non-randomized multicenter study of the SINE compound selinexor plus low-dose dexamethasone in combination with bortezomib and daratumumab
100 mg selinexor on days 1 8 15 and 22 plus 40 mg dexamethasone 20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor both weekly as continuous therapy
Bortezomib will be given via subcutaneous at dose of 13 mgm2 once weekly on days 1 8 15 and 22 during the cycles 1 to cycle 8 and on day 1 and day 15 of each cycle thereafter as continuous therapy
Daratumumab will be given via intravenous at dose of 16 mgKg on days 1 8 15 and 22 weekly during the cycles 1 and 2 every two weeks on days 1 and 15 during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy
Patients may continue indefinitely and there is no maximum treatment duration
100 mg selinexor on days 1 8 15 and 22 plus 40 mg dexamethasone 20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor both weekly as continuous therapy
Bortezomib will be given via subcutaneous at dose of 13 mgm2 once weekly on days 1 8 15 and 22 during the cycles 1 to cycle 8 and on day 1 and day 15 of each cycle thereafter as continuous therapy
Daratumumab will be given via intravenous at dose of 16 mgKg on days 1 8 15 and 22 weekly during the cycles 1 and 2 every two weeks on days 1 and 15 during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy
Patients may continue indefinitely and there is no maximum treatment duration
Detailed Description:
This is a Phase 2 single-arm open non-randomized multicenter study of the SINE compound selinexor plus low-dose dexamethasone in combination with bortezomib and daratumumab
Sixty-two patients with RR MM who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive SVDd until either disease progression or intolerance has occurred
Enrolled patients will take a fixed milligram dose of 100 mg selinexor on days 1 8 15 and 22 plus 40 mg dexamethasone 20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor both weekly as continuous therapy
Bortezomib will be given via subcutaneous at dose of 13 mgm2 once weekly on days 1 8 15 and 22 during the cycles 1 to cycle 8 and on day 1 and day 15 of each cycle thereafter as continuous therapy
Daratumumab will be given via intravenous at dose of 16 mgKg on days 1 8 15 and 22 weekly during the cycles 1 and 2 every two weeks on days 1 and 15 during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy
Patients may continue indefinitely and there is no maximum treatment duration
Sixty-two patients with RR MM who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive SVDd until either disease progression or intolerance has occurred
Enrolled patients will take a fixed milligram dose of 100 mg selinexor on days 1 8 15 and 22 plus 40 mg dexamethasone 20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor both weekly as continuous therapy
Bortezomib will be given via subcutaneous at dose of 13 mgm2 once weekly on days 1 8 15 and 22 during the cycles 1 to cycle 8 and on day 1 and day 15 of each cycle thereafter as continuous therapy
Daratumumab will be given via intravenous at dose of 16 mgKg on days 1 8 15 and 22 weekly during the cycles 1 and 2 every two weeks on days 1 and 15 during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy
Patients may continue indefinitely and there is no maximum treatment duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None