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Corticosteroid
Selinexor + Venetoclax + Dexamethasone for Multiple Myeloma (SELVEDge Trial)
Phase 2
Recruiting
Led By Dickran Kazandjian, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG).
Age ≥18 years of age on day of signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
SELVEDge Trial Summary
This trial will test whether combining selinexor, venetoclax, and dexamethasone can help patients with a certain type of myeloma that has relapsed or become refractory to treatment.
Who is the study for?
Adults diagnosed with relapsed/refractory multiple myeloma, specifically with t(11;14) translocation. Participants must have tried at least two prior therapies including IMiDs, proteasome inhibitors, and anti-CD38 monoclonal antibodies. They should not be pregnant or breastfeeding and must agree to use effective contraception. Excluded are those with uncontrolled infections, certain heart conditions, gastrointestinal issues affecting medication absorption, or any condition that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: Selinexor, Venetoclax, and Dexamethasone (XVenD), in patients who have a specific genetic feature in their cancer cells (t(11;14)) and whose disease has returned after treatment or did not respond to previous treatments.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting due to dexamethasone; fatigue and blood count changes from selinexor; diarrhea from venetoclax. There's also a risk of infection because these medications can weaken the immune system.
SELVEDge Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma according to IMWG criteria.
Select...
I am 18 years old or older.
Select...
I was diagnosed with high levels of M-protein or many plasma cells in my bone marrow, and I have at least one of the following: anemia, kidney failure, high calcium, bone damage, or abnormal blood tests.
Select...
My myeloma was confirmed with a specific genetic feature (t(11;14)) by a certified test.
Select...
I can take care of myself but may not be able to do heavy physical work.
Select...
I am using effective birth control and have a negative pregnancy test if I'm of childbearing age.
Select...
My multiple myeloma has returned after treatment.
SELVEDge Trial 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
Fraction of Participants Achieving Overall Response
Secondary outcome measures
Duration of Response (DoR)
Minimal Residual Disease Negative Complete Response Rate
Overall Survival (OS)
+2 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598572%
Weight Decreased
68%
Nausea
60%
Fatigue
56%
Anaemia
52%
Thrombocytopenia
48%
Decreased Appetite
44%
Dysgeusia
44%
Vomiting
24%
Dyspnoea
24%
Diarrhoea
24%
Dizziness
24%
Constipation
20%
Asthenia
20%
Insomnia
20%
Vision Blurred
16%
Pyrexia
16%
Dysuria
16%
Back Pain
16%
Pollakiuria
12%
Hypokalaemia
12%
Headache
12%
Peripheral Sensory Neuropathy
12%
Cough
12%
Haematuria
12%
Nasopharyngitis
12%
Abdominal Pain
12%
Musculoskeletal Chest Pain
12%
Hypomagnesaemia
12%
Anxiety
8%
Arthralgia
8%
Confusional State
8%
Hallucination
8%
Malaise
8%
Device Occlusion
8%
Oedema Peripheral
8%
Urinary Tract Infection
8%
Depression
8%
Abdominal Distension
8%
Abdominal Pain Upper
8%
Face Oedema
8%
Hyponatraemia
8%
Paraesthesia
8%
Night Sweats
8%
Hot Flush
8%
Vaginal Haemorrhage
4%
Haematemesis
4%
Visual Impairment
4%
Muscular Weakness
4%
Ear Discomfort
4%
Anal Haemorrhage
4%
Rectal Haemorrhage
4%
Urinary Retention
4%
Vertigo
4%
Renal Failure
4%
Lung Infection
4%
Dyspepsia
4%
Cystitis Noninfective
4%
Stomatitis
4%
Dry Mouth
4%
Hyperglycaemia
4%
Hyperkalaemia
4%
Bronchitis
4%
Pulmonary Embolism
4%
Hypertension
4%
Bacteraemia
4%
Cystitis
4%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 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
SELVEDge Trial Design
1Treatment groups
Experimental Treatment
Group I: XVenD GroupExperimental Treatment3 Interventions
Participants will receive XVenD combination therapy of Selinexor (X), Venetoclax (Ven) and Dexamethasone (D) orally during each 28-day cycle. Doses will be administered as follows:
Cycle 1 Days 1 to 7:
Venetoclax 400 mg orally (PO), Days 1-7
Dexamethasone 40 mg PO, Day 1
Cycle 1 Days 8 to 28:
Venetoclax 800 mg PO, Days 8-28
Dexamethasone 40 mg PO, Days 8, 15, and 22
Cycles 2 to 4:
Selinexor 80 mg PO, Days 1, 8, 15, and 22
Venetoclax 800 mg PO, Days 1-28
Dexamethasone 40 mg PO, Days 1, 8, 15, and 22
Cycle 5 and beyond:
Selinexor 80 mg PO, Days 1, 8, 15, and 22
Venetoclax 800 mg PO, Days 1-28
Dexamethasone 20 mg PO, Days 1, 8, 15, and 22
Selinexor dose will be reduced to 60 mg for remaining participants if after the first 6 participants complete the first cycle and 2 or more out of these first 6 participants experience dose-limiting toxicities (DLTs).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Venetoclax
2019
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
910 Previous Clinical Trials
411,597 Total Patients Enrolled
6 Trials studying Multiple Myeloma
1,384 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,606 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,187 Patients Enrolled for Multiple Myeloma
Dickran Kazandjian, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Multiple Myeloma
28 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent tests show my organs are working well.I do not have any health conditions that could affect the study.I do not have an active infection needing IV drugs within the last week.I am 18 years old or older.I do not have severe heart problems or a recent heart attack.I have controlled Hep B, untreated Hep C, or stable HIV with no recent severe infections.I can take care of myself but may not be able to do heavy physical work.I am allergic or cannot take certain medications needed for the trial.I am unable or unwilling to take recommended medications for nausea and weight loss.I have previously been treated with selinexor or a similar drug.I have been diagnosed with multiple myeloma according to IMWG criteria.I have no stomach or bowel problems affecting my ability to take pills.I was diagnosed with high levels of M-protein or many plasma cells in my bone marrow, and I have at least one of the following: anemia, kidney failure, high calcium, bone damage, or abnormal blood tests.My myeloma was confirmed with a specific genetic feature (t(11;14)) by a certified test.I've had 2 treatments for my condition and can't tolerate or take standard therapies.You have a documented measurable disease according to specific guidelines within the 4 weeks before signing up.I am using effective birth control and have a negative pregnancy test if I'm of childbearing age.My multiple myeloma has returned after treatment.You have had bad reactions or are not supposed to take glucocorticoids.
Research Study Groups:
This trial has the following groups:- Group 1: XVenD Group
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.
Has the US Food and Drug Administration cleared selinexor for use?
"Selinexor is currently in Phase 2 of clinical trials, so there is some evidence backing its safety but none yet for efficacy. Our team at Power gave it a score of 2."
Answered by AI
Are new participants being sought for this experiment?
"Unfortunately, this particular trial is not currently seeking patients according to the most recent update on clinicaltrials.gov. The study was posted on February 1st 2023 and updated November 11th 2022. Although 827 other trials are actively recruiting participants."
Answered by AI
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