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Corticosteroid
Selinexor + Pomalidomide + Dexamethasone ± Carfilzomib for Multiple Myeloma
Phase 1 & 2
Recruiting
Led By Prashant Kapoor, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow capsules and able to take and tolerate oral medications on a continuous basis
Diagnosis of RRMM with progressive disease at study entry as per the International Myeloma Working Group (IMWG) uniform criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing selinexor in combination with pomalidomide and dexamethasone, with or without carfilzomib, to see if it can help control relapsed refractory multiple myeloma.
Who is the study for?
Adults with relapsed refractory multiple myeloma who have previously been treated and are not responding to proteasome inhibitors and immunomodulatory drugs. Participants must be over 18, able to perform daily activities with minimal assistance (ECOG PS 0-2), capable of taking oral medication, willing to use birth control, and have adequate organ function. They cannot join if they've had major surgery within the last 21 days or have certain severe diseases, allergies specific to trial medications, active infections requiring systemic treatment within the past two weeks, or uncontrolled illnesses.Check my eligibility
What is being tested?
The SCOPE Trial is testing selinexor in combination with pomalidomide and dexamethasone against the same combination plus carfilzomib for treating patients whose multiple myeloma has returned after previous treatments. The study aims to find out the best dose of selinexor and its side effects when used in these combinations.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues reflected by altered blood tests results; there may also be risks related to heart health such as changes in blood pressure or heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills and tolerate them without issues.
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My multiple myeloma is worsening despite treatment.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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Arm A: You have been treated with at least three prior lines of therapy, including certain medications. If you are not responsive to carfilzomib and/or pomalidomide, you may still join Arm A under certain conditions. Arm B: You have shown disease progression and have received up to two prior lines of therapy, including specific medications.
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My white blood cell count is healthy without needing medication for over a week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of selinexor in combination with carfilzomib, pomalidomide and dexamethasone (Phase I)
Proportion of patients who achieve a confirmed response with selinexor in combination with pomalidomide and dexamethasone (Phase 2)
Secondary outcome measures
Clinical benefit rate
Duration of response
Incidence of adverse events
+2 moreOther outcome measures
Minimal residual disease (MRD)
Overall health-related quality of life
Patient reported outcomes (PRO)
+1 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (selinexor, dexamethasone, pomalidomide)Experimental Treatment11 Interventions
Patients receive selinexor PO and dexamethasone PO on days 1, 8, 15, and 22, and pomalidomide PO on days 1-21. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT and bone marrow biopsy and aspiration during screening and on the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Group II: Arm A (selinexor, dexamethasone, carfilzomib, carfilzomib)Experimental Treatment12 Interventions
Patients receive selinexor PO and dexamethasone PO on days 1, 8 15, and 22, carfilzomib IV on days 1, 8, and 15, and pomalidomide PO on days 1-21. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT and bone marrow biopsy and aspiration during screening and on the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Dexamethasone
2007
Completed Phase 4
~2590
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1700
Pomalidomide
2011
Completed Phase 2
~1020
Carfilzomib
2017
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,948 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,050 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,930 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,630 Patients Enrolled for Multiple Myeloma
Prashant Kapoor, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Multiple Myeloma
18 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are able to have children, you must have a negative pregnancy test within 7 days before joining the study.Your total bilirubin level should be no higher than 2 times the upper limit of normal, unless you have Gilbert's syndrome, in which case it should be no higher than 3 times the upper limit of normal.I am allergic to Captisol, a substance used in some medications.I have not had plasmapheresis within the last 28 days.I am allergic to thalidomide, lenalidomide, or dexamethasone.I haven't had any bleeding issues or coagulation problems in the last month.Your liver enzymes (ALT and AST) should not be more than 2.5 times the upper limit of normal.I have been diagnosed with SMM, MGUS, Waldenström's macroglobulinemia, or AL amyloidosis.I am willing to follow the study's strict birth control guidelines.My blood pressure and diabetes have been under control for the last 2 weeks.I still feel side effects from my last treatment, except for mild, stable nerve issues.I do not have a condition that affects how my body absorbs pills.I can swallow pills and tolerate them without issues.My multiple myeloma is worsening despite treatment.Pomalidomide and carfilzomib (or just pomalidomide for Arm B) are not available to me.I am allergic or cannot tolerate certain medications needed alongside my cancer treatment.Your blood clotting time is within a normal range.I have not had severe nerve pain or damage in the last 2 weeks.I haven't had cancer treatment except possibly one small radiation dose in the last 2 weeks.I am 18 years old or older.I cannot or do not want to take blood clot prevention medication.I do not have an active hepatitis A, B, or C infection.I have a history of frequent infections or specific blood or systemic disorders.I am able to care for myself and perform daily activities.I haven't needed fluid removed from my chest or abdomen in the last 14 days.I have measurable signs of myeloma according to specific blood, urine, or imaging tests.Arm A: You have been treated with at least three prior lines of therapy, including certain medications. If you are not responsive to carfilzomib and/or pomalidomide, you may still join Arm A under certain conditions. Arm B: You have shown disease progression and have received up to two prior lines of therapy, including specific medications.My kidney function, measured by creatinine clearance, is adequate.My white blood cell count is healthy without needing medication for over a week.I am currently on or have recently stopped taking medication that affects my immune system.My hemoglobin level is at least 8.0 g/dL without recent transfusions.I do not have any severe illnesses or conditions that would stop me from following the study's requirements.I have not had a recent heart attack or severe heart issues.I have not received a live vaccine in the last 30 days.I have not had major surgery in the last 3 weeks.I have lung inflammation that is not caused by an infection.I have been treated with Selinexor before.I am willing to undergo up to 18 cycles of therapy for my multiple myeloma.My platelet count is high enough without recent transfusions.I haven't had any cancer except for non-melanoma skin cancer or cervical carcinoma-in-situ in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (selinexor, dexamethasone, pomalidomide)
- Group 2: Arm A (selinexor, dexamethasone, carfilzomib, carfilzomib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the positions for this experiment still open to applicants?
"According to clinicaltrials.gov, this medical study is actively accepting participants. The trial was first published on May 6th 2021 and the latest update was posted June 3rd 2022."
Answered by AI
How many participants are involved in this clinical research experiment?
"Affirmative. The details hosted on clinicaltrials.gov verify that recruitment for this medical study is still ongoing; it was first released in May of 2021 and last modified in June of 2022, aiming to enrol 81 participants at one site."
Answered by AI
What are the key aims of this experiment?
"The primary goal of this clinical trial, to be monitored over a period up to 3 years, is to determine the maximum tolerated dose of selinexor in combination with carfilzomib, pomalidomide and dexamethasone (Phase I). Secondary objectives include assessing incidence of adverse events through severity grade tabulation; determining duration of response for those that obtain confirmatory responses; and evaluating overall survival using Kaplan-Meier method."
Answered by AI
What medical conditions can Selinexor be employed to ameliorate?
"Selinexor is frequently prescribed to treat ophthalmia, sympathetic. It can equally be used as a curative measure for communicable illnesses and conditions such as branch retinal vein occlusion and macular edema."
Answered by AI
Have other researchers explored the implications of Selinexor in their investigations?
"Currently, there are 607 studies surrounding Selinexor with 147 in the third stage of clinical trials. Although most locations for these investigations are based out of Joliet Illinois, multiple sites across 19429 areas have been enrolled to carry out this medication's assessment."
Answered by AI
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