NCT05028348

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: European Myeloma Network B.V. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor will be given as an oral dose 40 mg (2 20 mg tablets) QW on Days 1, 8, 15, and 22 of each 28-day cycle.
DRUG	Elotuzumab	Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.
DRUG	Pomalidomide	Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
DRUG	Dexamethasone Oral	Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Preferred dosing of dexamethasone is 40 mg QW for patients who are ≤75 years of age (20 mg QW for \>75-year-old patients at the Investigator's discretion) before QW dosing of selinexor, however, it may be divided over 2 days at the Investigator's discretion.

Timeline

• Start date: 2022-04-19
• Primary completion: 2026-03-01
• Completion: 2029-03-01
• First posted: 2021-08-31
• Last updated: 2025-12-04

Locations

20 sites across 4 countries: France, Germany, Greece, Spain