A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Conditions

R/R Multiple Myeloma

Brief summary

The primary efficacy endpoint is progression-free survival (PFS) per Independent Review Committee (IRC) based on IMWG criteria. PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

Detailed description

Overall response rate (ORR) per the independent review committee (IRC), Rate of very good partial response (VGPR) or better per the IRC, Overall survival (OS), Minimal residual disease (MRD) negativity rate, Time to deterioration in disease symptoms as measured by the disease symptom domain of the EORTC QLQ-MY20, Time to deterioration in physical functioning as measured by the physical functioning domain of EORTC QLQ-C30, Other Patient reported outcomes (PROs) assessed using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a, Brief Pain Inventory –Short Form [(BPI-SF]), EuroQoL 5 Dimension 5 Level (EQ5D5L) and remaining domains of EORTC QLQ-MY20, and EORTC QLQ-C30 survey instruments, Duration of response (DOR), Time to disease progression (TTP), Time to response (TTR), Pharmacokinetics of venetoclax, Safety

Related papers

No related papers found yet.

Interventions

DRUGImnovid 3 mg hard capsules

DRUGDEXAMETHASONE

DRUGVenetoclax

DRUGImnovid 1 mg hard capsules

DRUGImnovid 4 mg hard capsules

DRUGImnovid 2 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is progression-free survival (PFS) per Independent Review Committee (IRC) based on IMWG criteria. PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.	—

Secondary

Measure	Time frame
Overall response rate (ORR) per the independent review committee (IRC), Rate of very good partial response (VGPR) or better per the IRC, Overall survival (OS), Minimal residual disease (MRD) negativity rate, Time to deterioration in disease symptoms as measured by the disease symptom domain of the EORTC QLQ-MY20, Time to deterioration in physical functioning as measured by the physical functioning domain of EORTC QLQ-C30, Other Patient reported outcomes (PROs) assessed using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a, Brief Pain Inventory –Short Form [(BPI-SF]), EuroQoL 5 Dimension 5 Level (EQ5D5L) and remaining domains of EORTC QLQ-MY20, and EORTC QLQ-C30 survey instruments, Duration of response (DOR), Time to disease progression (TTP), Time to response (TTR), Pharmacokinetics of venetoclax, Safety	—

Measure

Time frame

Overall response rate (ORR) per the independent review committee (IRC), Rate of very good partial response (VGPR) or better per the IRC, Overall survival (OS), Minimal residual disease (MRD) negativity rate, Time to deterioration in disease symptoms as measured by the disease symptom domain of the EORTC QLQ-MY20, Time to deterioration in physical functioning as measured by the physical functioning domain of EORTC QLQ-C30, Other Patient reported outcomes (PROs) assessed using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a, Brief Pain Inventory –Short Form [(BPI-SF]), EuroQoL 5 Dimension 5 Level (EQ5D5L) and remaining domains of EORTC QLQ-MY20, and EORTC QLQ-C30 survey instruments, Duration of response (DOR), Time to disease progression (TTP), Time to response (TTR), Pharmacokinetics of venetoclax, Safety

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Countries

Czechia, Denmark, France, Germany, Greece, Italy, Spain

Outcome results

None listed