A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma
1. Progression-free survival (PFS) (Time Frame - from randomization to the date of disease progression or death (approximately up to 5 years)): 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 outcome:
1. Overall Response Rate (ORR) (Time Frame - from screening until end of treatment/progressive disease (approximately up to 2 years)): defined as any response ≥PR (i.e., PR [partial response], VGPR [very good partial response], CR ([complete response], or sCR [stringent complete response])
2. Overall survival (OS) (Time Frame - From randomization until death from any cause (up to 3 years after end of treatment)): Overall Survival
3. Duration of response (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): 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.
4. Time to response (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 (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR)
5. Progression-free survival on the next line of therapy (PFS2) (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): 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.
6. 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 (Time Frame - screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (up to 2 years)): 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.
7. Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score and the difference between-treatment arms (Time Frame - screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)): 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.
8. EQ-5D-5L health utility values and the difference between-treatment arms (Time Frame - screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)): 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"
9. safety and tolerability of SPd versus EloPd in patients with RRMM (Time Frame - continuously from screening untill 30 days after last study treatment. (approximately up to 2 years)): 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
Experimental: Selinexor, pomalidomide and dexamethasone (SPd) Selinexor will be given as an oral dose:
40 mg (2 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 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.
Patients ≤75 years:
o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Patients > 75 years:
Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Active Comparator: Elotuzumab, Pomalidomide and Dexamethasone (EloPd) 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 once a day (QD) on Days 1 to 21 of each 28-day cycle.
Patients ≤75 years:
Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing
Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Patients >75 years:
Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing
Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Selinexor (KPT-330): 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: 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: Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
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.
Quelle: ClinicalTrials.gov
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