Penta-refractory multiple myeloma and triple-class refractory multiple myeloma
Conditions
Brief summary
ORR defined as the proportion of patients who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as assessed by the Investigator based on International Myeloma Working Group (IMWG) response criteria will be analyzed separately for each arm
Detailed description
The following endpoints will be analyzed separately for each arm: • Duration of response (DOR) • Clinical benefit rate (CBR) • Disease control rate (DCR) • Progression-free survival (PFS) • Overall survival (OS) • Time to next treatment (TTNT), The safety and tolerability of study drug will be evaluated based on AE reports, vital signs, and clinical laboratory results by means of the occurrence, nature, and severity of AEs as categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Interventions
DRUGZYPREXA 2.5 mg coated tablets
DRUGSELINEXOR
Sponsors
Karyopharm Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR defined as the proportion of patients who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as assessed by the Investigator based on International Myeloma Working Group (IMWG) response criteria will be analyzed separately for each arm | — |
Secondary
| Measure | Time frame |
|---|---|
| The following endpoints will be analyzed separately for each arm: • Duration of response (DOR) • Clinical benefit rate (CBR) • Disease control rate (DCR) • Progression-free survival (PFS) • Overall survival (OS) • Time to next treatment (TTNT), The safety and tolerability of study drug will be evaluated based on AE reports, vital signs, and clinical laboratory results by means of the occurrence, nature, and severity of AEs as categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | — |
Countries
Greece
Outcome results
None listed