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Monoclonal Antibodies
Selinexor + DRd for Multiple Myeloma
Phase 2
Recruiting
Led By Robert M Rifkin, MD, FACP
Research Sponsored by US Oncology Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will study the effects of selinexor in combination with daratumumab, lenalidomide, and dexamethasone as a first-line treatment for multiple myeloma.
Who is the study for?
Adults with untreated multiple myeloma can join this trial. They must be able to follow the study plan and use effective birth control if they can have children. People who've had major surgery recently, have brain involvement by myeloma, HIV, hepatitis B or C, serious heart issues, or certain blood conditions cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination of four drugs: Selinexor plus Daratumumab, Lenalidomide, and Dexamethasone (S-DRd) as a first-line treatment for multiple myeloma. It's an open-label phase II study where everyone gets the same treatment.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems; some may experience nerve damage or changes in liver function tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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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My myeloma has not been treated before.
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I am not pregnant and agree to use effective birth control.
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My condition is officially diagnosed as multiple myeloma.
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I am a man and use effective birth control methods if sexually active.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate (CR)
Safety of Selinexor plus DRd
Stringent Complete Response Rate (sCR)
Secondary outcome measures
Duration of Response
Minimal Residual Disease (MRD)
Objective Response Rate (ORR)
+3 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
1Treatment groups
Experimental Treatment
Group I: Selinexor plus DRdExperimental Treatment4 Interventions
Lenalidomide 15 mg orally on Days 1-21 of each 28-day cycle
Dexamethasone 40 mg on Days 1, 8, 15, 22 of each cycle. However, those >75 years old may be administered a weekly dose of 20 mg dexamethasone.
Daratumumab 1800 mg subcutaneous injection once weekly in Cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter.
Selinexor 60 mg on Days 1, 8, 15, of cycles 1-3, with a planned dose-reduction to 40 mg on Days 1, 8, 15 for cycles beyond 3. If patient was previously dose reduced prior to cycle 4, then at cycle 4 planned dose reduction, you will again decrease dose by 1 level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Daratumumab
2014
Completed Phase 3
~1860
Selinexor
2020
Completed Phase 2
~1360
Dexamethasone Oral
2020
N/A
~14110
Find a Location
Who is running the clinical trial?
US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,362 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,479 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,120 Patients Enrolled for Multiple Myeloma
Robert M Rifkin, MD, FACPPrincipal InvestigatorUS Oncology Research/McKesson Specialty Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that could affect the study.You are thinking about getting pregnant.I am 18 years old or older.My multiple myeloma has affected my brain or spinal cord.I am able to care for myself and perform daily activities.I have a specific condition like plasma cell leukemia or Waldenström's.You have a detectable disease that meets certain standards.My myeloma has not been treated before.You have certain abnormal test results during the initial check-up.I am not pregnant and agree to use effective birth control.I am eligible for a stem cell transplant.My condition is officially diagnosed as multiple myeloma.You have HIV, hepatitis B, or a history of hepatitis C.I have a serious heart condition.I am a man and use effective birth control methods if sexually active.I haven't had major surgery in the last 2 weeks and don't plan any during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Selinexor plus DRd
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 FDA greenlighted Selinexor for public use?
"We have assigned Selinexor a safety rating of 2 due to the fact that while there is some evidence confirming its security, it has yet to be proven effective in Phase 2 trials."
Answered by AI
Are there opportunities for enrolment into this experiment currently?
"Affirmative. According to the clinicaltrials.gov portal, this medical study first started recruiting on September 10th 2021 and is still open for applications. The trial seeks 100 patients across 11 different sites."
Answered by AI
What other investigations have taken place regarding Selinexor?
"The initial assessment of selinexor took place at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. Since then, 1385 trials have been completed and 772 studies are still underway; the majority of these active experiments take place around Albany, New york."
Answered by AI
What indications are typically addressed with Selinexor?
"Selinexor can be utilized to treat ophthalmia, sympathetic conditions, those who have received two or more systemic chemotherapy regimens, and cases of branch retinal vein occlusion."
Answered by AI
What aims does this medical trial hope to accomplish?
"This 6-month clinical trial is designed to measure the safety of Selinexor plus DRd, with secondary objectives that include Duration of Response (time from initial progress until progression or death), Progression-Free Survival (median time between randomization and disease progression/death) and Overall Survival (median time from randomization until death)."
Answered by AI
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