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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
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.
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.
Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
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.
CHRU Hôtel Dieu
Nantes, France
CHU Hôpital Saint Antoine
Paris, France
La Pitié
Paris, France
Klinikum Chemnitz
Chemnitz, Germany
Marien Hospital Dusseldorf
Düsseldorf, Germany
University Medicine Greifswald, Medical Clinic and Polyclinic for Internal Medicine
Greifswald, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, Germany
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, Greece
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
...and 10 more locations
Progression-free survival (PFS)
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.
Time frame: from randomization to the date of disease progression or death (approximately up to 5 years)
Overall Response Rate (ORR)
defined as any response ≥PR (i.e., PR \[partial response\], VGPR \[very good partial response\], CR (\[complete response\], or sCR \[stringent complete response\])
Time frame: from screening until end of treatment/progressive disease (approximately up to 2 years)
Overall survival (OS)
Overall Survival
Time frame: From randomization until death from any cause (up to 3 years after end of treatment)
Duration of response
Duration of response (PR or better), duration of CR, duration of sCR, and duration of minimal residual disease (MRD) -negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, whichever occurs first.
Time frame: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment, and every 3 months up to 3 years
Time to response
Time to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR)
Time frame: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment, and every 3 months up to 3 years
Progression-free survival on the next line of therapy (PFS2)
Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.
Time frame: the time from randomization to progression on the next line of treatment or death, whichever comes first., assessed up to approx. 5 years
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms
The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.
Time frame: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (up to 2 years)
Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score and the difference between-treatment arms
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Time frame: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)
EQ-5D-5L health utility values and the difference between-treatment arms
The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
Time frame: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)
safety and tolerability of SPd versus EloPd in patients with RRMM
Safety and tolerability of study treatment will be evaluated based on occurrence, nature and severity of adverse events as categorized by the Common Terminology Criteria of Adverse Events (CTCAE) v5.0
Time frame: continuously from screening untill 30 days after last study treatment. (approximately up to 2 years)
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