A PHASE 3 RANDOMIZED, OPEN-LABEL TRIAL OF SELINEXOR, POMALIDOMIDE, AND DEXAMETHASONE (SPd) VERSUS ELOTUZUMAB, POMALIDOMIDE, AND DEXAMETHASONE (EloPd) IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Brief summary

PFS, defined as time from date of randomization until the date of first confirmed progressive disease (PD), per IMWG response criteria, or death due to any cause, whichever occurs first

Detailed description

Key secondary efficacy endpoints: • ORR, defined as any response ≥PR • Overall survival (OS) Additional secondary efficacy endpoints: • Clinical benefit rate (CBR), defined as response ≥minimal response (MR) • Duration of response (DOR) • Time to next treatment (TNT) • Time to initial response (TTR) • Time to best response (TTBR) • Time to progression after first post-SPd/EloPd treatment or death (PFS2), Safety and tolerability of study treatment will be evaluated based on AE reports, vital signs, clinical laboratory results, electrocardiogram (ECG) and physical examination findings, by means of the occurrence, nature, and severity of AEs as categorized by the CTCAE v5.0, Patient-reported quality of life (QoL, as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life (EORTC-QLQ-C30), EORTC-QLQ-MY20, and EQ-5D-5L instruments, Selinexor and pomalidomide PK parameters, estimations of maximum plasma concentration, area under the concentration versus time curve (AUC), and apparent clearance, if feasible.

Related papers

No related papers found yet.

Interventions

DRUGDexamethason 4 mg JENAPHARM®

DRUGImnovid 4 mg hard capsules

DRUGEmpliciti 400 mg powder for concentrate for solution for infusion.

DRUGImnovid 1 mg hard capsules

DRUGSELINEXOR

DRUGImnovid 2 mg hard capsules

DRUGImnovid 3 mg hard capsules

DRUGDexa 8 mg inject JENAPHARM Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS, defined as time from date of randomization until the date of first confirmed progressive disease (PD), per IMWG response criteria, or death due to any cause, whichever occurs first	—

Secondary

Measure	Time frame
Key secondary efficacy endpoints: • ORR, defined as any response ≥PR • Overall survival (OS) Additional secondary efficacy endpoints: • Clinical benefit rate (CBR), defined as response ≥minimal response (MR) • Duration of response (DOR) • Time to next treatment (TNT) • Time to initial response (TTR) • Time to best response (TTBR) • Time to progression after first post-SPd/EloPd treatment or death (PFS2), Safety and tolerability of study treatment will be evaluated based on AE reports, vital signs, clinical laboratory results, electrocardiogram (ECG) and physical examination findings, by means of the occurrence, nature, and severity of AEs as categorized by the CTCAE v5.0, Patient-reported quality of life (QoL, as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life (EORTC-QLQ-C30), EORTC-QLQ-MY20, and EQ-5D-5L instruments, Selinexor and pomalidomide PK parameters, estimations of maximum plasma concentration, area under the concentration versus time	—

Measure

Time frame

Key secondary efficacy endpoints: • ORR, defined as any response ≥PR • Overall survival (OS) Additional secondary efficacy endpoints: • Clinical benefit rate (CBR), defined as response ≥minimal response (MR) • Duration of response (DOR) • Time to next treatment (TNT) • Time to initial response (TTR) • Time to best response (TTBR) • Time to progression after first post-SPd/EloPd treatment or death (PFS2), Safety and tolerability of study treatment will be evaluated based on AE reports, vital signs, clinical laboratory results, electrocardiogram (ECG) and physical examination findings, by means of the occurrence, nature, and severity of AEs as categorized by the CTCAE v5.0, Patient-reported quality of life (QoL, as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life (EORTC-QLQ-C30), EORTC-QLQ-MY20, and EQ-5D-5L instruments, Selinexor and pomalidomide PK parameters, estimations of maximum plasma concentration, area under the concentration versus time

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Countries

France, Germany, Greece, Italy, Netherlands, Spain

Outcome results

None listed