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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Smoldering Multiple Myeloma

Phase 2
Recruiting
Led By Jodi Lipof
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein >/= 3 g/dL or BMPC >10% but <60%, or both
Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk: BMPC>/=20%, M-spike >/= 2g/dL, Involved to uninvolved sFLC ratio of >/= 20, normal hepatic function within 28 days prior to C1D1, Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl >/= 15 mL/min, Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)>/=1.5 x10^9/L, hemoglobin >/=10g/dL, platelets >/150x10^9/L, Life expectancy of >12 months, ECOG PS 0-1, Subjects with reproductive potential must use 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 6 months after the study has closed, Ability to understand and willingness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after end of treament
Awards & highlights

Study Summary

This trial is studying the effects of a drug, selinexor, on smoldering multiple myeloma to help delay disease progression.

Who is the study for?
This trial is for adults over 18 with intermediate to high-risk Smoldering Multiple Myeloma (SMM), which hasn't progressed to full-blown multiple myeloma. Participants need proper liver and kidney function, no severe bone damage from the disease, and a life expectancy of more than a year. They must not have other active cancers or infections, be pregnant, or refuse effective contraception.Check my eligibility
What is being tested?
The study tests low-dose Selinexor in patients with SMM at intermediate or high risk of developing symptomatic multiple myeloma. The goal is to see if Selinexor can delay the progression of SMM to an active form of cancer.See study design
What are the potential side effects?
Selinexor may cause nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea, constipation, blood count changes increasing infection risk; rarely it might affect liver enzymes and cause shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with smoldering multiple myeloma as per IMWG standards.
Select...
You must have certain levels of specific substances in your blood, healthy liver and kidney function, and good blood cell counts. You must also have a good life expectancy, be in good overall health, and use effective birth control during the study.
Select...
I don't have high calcium, anemia, bone damage, or kidney issues due to my blood disorder.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after end of treament
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after end of treament for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of progression to Multiple Myeloma
Secondary outcome measures
Body Weight Changes
Progression free survival
Rate of skeletal related events
+1 more

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
78%
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: Experimental: TreatmentExperimental Treatment1 Intervention
Selinexor 40mg weekly for up to 12 cycles. Each cycle will be 28 days in length.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
836 Previous Clinical Trials
518,153 Total Patients Enrolled
11 Trials studying Multiple Myeloma
311 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,564 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,205 Patients Enrolled for Multiple Myeloma
Jodi LipofPrincipal InvestigatorUniversity of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have expressed interest in enrolling in this clinical experiment?

"Indeed, the evidence posted on clinicaltrials.gov reveals that this trial is presently recruiting participants. It was initially listed on August 21st 2023 and last updated on September 1st 20203. The team needs to recruit 15 people from one eligible location."

Answered by AI

Is access to this research available for qualified participants?

"Data on clinicaltrials.gov indicates that the screening process for this trial is still ongoing, having begun on August 21st 2023 and last updated September 1st of the same year."

Answered by AI

Has the Experimental: Treatment protocol been granted regulatory approval by the FDA?

"Our team at Power assesses the safety of Experimental: Treatment to be a 2, as there is some data that suggests it is safe but no evidence yet proving its efficacy."

Answered by AI
~7 spots leftby Dec 2024