Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764942
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2021-02-17
Brief Title:
Selinexor Pomalidomide and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma The SCOPE Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase 12 Trial of Selinexor in Combination With Pomalidomide and Dexamethasone Carfilzomib for Patients With Proteasome-Inhibitor and Immunomodulatory Drug Refractory Multiple Myeloma SCOPE
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial identifies the best dose and side effects of selinexor and how well it works when given in combination with pomalidomide and dexamethasone with or without carfilzomib in treating patients with multiple myeloma that has come back relapsed and does not respond to treatment with proteasome inhibitors and immunomodulatory drugs refractory Selinexor is an oral agent that blocks a protein called Exportin 1 XPO1 or CRM1 that is abundant in a wide variety of cancers including multiple myeloma Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Pomalidomide may stop the growth of blood vessels stimulate the immune system and kill cancer cells Anti-inflammatory drugs such as dexamethasone may lower the bodys immune response and are used with other drugs in the treatment of some types of cancer The addition of selinexor may allow better control of relapsed refractory multiple myeloma than is possible with pomalidomide and dexamethasone with or without carfilzomib
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of selinexor in combination with carfilzomib pomalidomide and dexamethasone SKPd in patients with relapsed refractory multiple myeloma RRMM Arm A II To determine the efficacy of fixed-dose selinexor in combination with low-dose pomalidomide and dexamethasone SPd in patients with RRMM as measured by the overall response rate ORR per the International Myeloma Working Group IMWG criteria Arm B
SECONDARY OBJECTIVES
I To evaluate the preliminary efficacy of SKPd in relapsedrefractory multiple myeloma as measured by the overall response rate ORR per International Myeloma Working Group IMWG criteria and the duration of response DOR Arm A II To evaluate clinical benefit rate CBR duration of response progression-free survival overall survival and the safety profile of SPd Arm B
EXPLORATORY OBJECTIVES
I To estimate clinical activity in different risk groups by cytogenetics II To assess minimal residual disease by flow cytometry in patients achieving complete response CR and compare the outcomes of patients who are serum mass-fix mass spectrometry-based methodology available at Mayo Clinic negative only versus those who have no evidence of disease by mass fix and flow-cytometry-based minimal residual disease MRD
III To assess overall health-related quality of life as measured by the global health domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Quality of Life Questionnaire-Multiple Myeloma 20 QLQ-MY20
IV To evaluate patient reported outcomes using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events PRO-CTCAE
V To stratify patients in arm A based on quadruplepenta-refractory status and to assess the impact of this stratification on patient outcomes
VI To stratify patients in arm B based on their dual-refractory status and to assess the impact of this stratification on patient outcomes
OUTLINE Patients with 3 prior lines of therapy are assigned to Arm A while patients with 1-2 prior lines of therapy are assigned to Arm B Arm A is a phase I dose-escalation study of selinexor and carfilzomib with fixed-dose dexamethasone and pomalidomide followed by a dose-expansion study Arm B is a phase II fixed-dose study of selinexor dexamethasone and pomalidomide
ARM A Patients receive selinexor orally PO and dexamethasone PO on days 1 8 15 and 22 carfilzomib intravenously IV on days 1 8 and 15 and pomalidomide PO on days 1-21 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients undergo x-ray imaging during screening Patients also undergo positron emission tomographycomputed tomography PETCT or CT and bone marrow biopsy and aspiration during screening and on the trial Patients may optionally undergo blood sample collection during screening and on the trial
ARM B Patients receive selinexor PO and dexamethasone PO on days 1 8 15 and 22 and pomalidomide PO on days 1-21 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients undergo x-ray imaging during screening Patients also undergo PETCT or CT and bone marrow biopsy and aspiration during screening and on the trial Patients may optionally undergo blood sample collection during screening and on the trial
After completion of study treatment patients are followed up at 30 days then every 3 months until progressive disease PD or subsequent treatment then every 6 months until 3 years from registration
I To determine the maximum tolerated dose MTD of selinexor in combination with carfilzomib pomalidomide and dexamethasone SKPd in patients with relapsed refractory multiple myeloma RRMM Arm A II To determine the efficacy of fixed-dose selinexor in combination with low-dose pomalidomide and dexamethasone SPd in patients with RRMM as measured by the overall response rate ORR per the International Myeloma Working Group IMWG criteria Arm B
SECONDARY OBJECTIVES
I To evaluate the preliminary efficacy of SKPd in relapsedrefractory multiple myeloma as measured by the overall response rate ORR per International Myeloma Working Group IMWG criteria and the duration of response DOR Arm A II To evaluate clinical benefit rate CBR duration of response progression-free survival overall survival and the safety profile of SPd Arm B
EXPLORATORY OBJECTIVES
I To estimate clinical activity in different risk groups by cytogenetics II To assess minimal residual disease by flow cytometry in patients achieving complete response CR and compare the outcomes of patients who are serum mass-fix mass spectrometry-based methodology available at Mayo Clinic negative only versus those who have no evidence of disease by mass fix and flow-cytometry-based minimal residual disease MRD
III To assess overall health-related quality of life as measured by the global health domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Quality of Life Questionnaire-Multiple Myeloma 20 QLQ-MY20
IV To evaluate patient reported outcomes using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events PRO-CTCAE
V To stratify patients in arm A based on quadruplepenta-refractory status and to assess the impact of this stratification on patient outcomes
VI To stratify patients in arm B based on their dual-refractory status and to assess the impact of this stratification on patient outcomes
OUTLINE Patients with 3 prior lines of therapy are assigned to Arm A while patients with 1-2 prior lines of therapy are assigned to Arm B Arm A is a phase I dose-escalation study of selinexor and carfilzomib with fixed-dose dexamethasone and pomalidomide followed by a dose-expansion study Arm B is a phase II fixed-dose study of selinexor dexamethasone and pomalidomide
ARM A Patients receive selinexor orally PO and dexamethasone PO on days 1 8 15 and 22 carfilzomib intravenously IV on days 1 8 and 15 and pomalidomide PO on days 1-21 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients undergo x-ray imaging during screening Patients also undergo positron emission tomographycomputed tomography PETCT or CT and bone marrow biopsy and aspiration during screening and on the trial Patients may optionally undergo blood sample collection during screening and on the trial
ARM B Patients receive selinexor PO and dexamethasone PO on days 1 8 15 and 22 and pomalidomide PO on days 1-21 Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity Patients undergo x-ray imaging during screening Patients also undergo PETCT or CT and bone marrow biopsy and aspiration during screening and on the trial Patients may optionally undergo blood sample collection during screening and on the trial
After completion of study treatment patients are followed up at 30 days then every 3 months until progressive disease PD or subsequent treatment then every 6 months until 3 years from registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-01268 | REGISTRY | CTRP Clinical Trial Reporting Program | None |