Selinexor with alternating bortezomib or lenalidomide plus dexamethasone in transplant ineligible newly diagnosed multiple myeloma patients (SABLe): An Investigator Sponsored Trial

Conditions

Multiple Myeloma

Brief summary

ORR at end of induction, with response defined according to IMWG response criteria

Detailed description

VGPR rate at end of induction, MRD negativity by NGS at end of induction, Time to at least PR from start of treatment, Time to at least VGPR from start of treatment, Toxicity rates according to NCI-CTCAE v4.03, Rates of neuropathy according to NCI-CTCAE, Rates of documented thrombosis, Rates of administrated vs planned doses, Number of patients of patients finalizing all 16 cycles of planned induction, Toxicity rates (frequency, severity and interference) during treatment according to NCI PRO-CTCAE registrations, Change from baseline to end of treatment in the key PRO domains of functioning (physical, social and emotional) overall QoL and symptoms of fatigue and nausea, OS, PFS, TNT, Changes in gene expression at baseline from patients responding and not-responding to selinexor

Related papers

No related papers found yet.

Interventions

DRUGSELINEXOR

DRUGBORTEZOMIB

DRUGLENALIDOMIDE

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR at end of induction, with response defined according to IMWG response criteria	—

Secondary

Measure	Time frame
VGPR rate at end of induction, MRD negativity by NGS at end of induction, Time to at least PR from start of treatment, Time to at least VGPR from start of treatment, Toxicity rates according to NCI-CTCAE v4.03, Rates of neuropathy according to NCI-CTCAE, Rates of documented thrombosis, Rates of administrated vs planned doses, Number of patients of patients finalizing all 16 cycles of planned induction, Toxicity rates (frequency, severity and interference) during treatment according to NCI PRO-CTCAE registrations, Change from baseline to end of treatment in the key PRO domains of functioning (physical, social and emotional) overall QoL and symptoms of fatigue and nausea, OS, PFS, TNT, Changes in gene expression at baseline from patients responding and not-responding to selinexor	—

Measure

Time frame

VGPR rate at end of induction, MRD negativity by NGS at end of induction, Time to at least PR from start of treatment, Time to at least VGPR from start of treatment, Toxicity rates according to NCI-CTCAE v4.03, Rates of neuropathy according to NCI-CTCAE, Rates of documented thrombosis, Rates of administrated vs planned doses, Number of patients of patients finalizing all 16 cycles of planned induction, Toxicity rates (frequency, severity and interference) during treatment according to NCI PRO-CTCAE registrations, Change from baseline to end of treatment in the key PRO domains of functioning (physical, social and emotional) overall QoL and symptoms of fatigue and nausea, OS, PFS, TNT, Changes in gene expression at baseline from patients responding and not-responding to selinexor

—

Countries

Denmark, Estonia, Norway

Outcome results

None listed