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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 not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after end of treament
Awards & highlights

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...
I don't have high calcium, anemia, bone damage, or kidney issues due to my blood disorder.
Select...
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 2021 Phase 2 & 3 trial • 342 Patients • NCT02606461
71%
Nausea
52%
Fatigue
51%
Decreased appetite
49%
Vomiting
41%
Anaemia
40%
Weight decreased
38%
Thrombocytopenia
29%
Diarrhoea
22%
Constipation
21%
Asthenia
21%
Leukopenia
21%
Abdominal pain
19%
Neutropenia
19%
Dysgeusia
17%
Hyponatraemia
17%
Dizziness
16%
Oedema peripheral
16%
Dyspnoea
14%
Hypercreatininaemia
13%
Pyrexia
13%
Vision Blurred
12%
Vision blurred
11%
Headache
11%
Sinus tachycardia
11%
Hyperglycaemia
11%
Hypophosphataemia
11%
Back pain
11%
Cough
11%
Aspartate aminotransferase increased
10%
Lymphopenia
10%
Sinus Tachycardia
10%
Hypertension
10%
Alanine aminotransferase increased
8%
Hyperkalaemia
8%
Blood alkaline phosphatase increased
8%
Hypoalbuminaemia
8%
Muscular weakness
8%
Pain in extremity
8%
Taste disorder
8%
Depression
8%
Hypotension
7%
Anxiety
7%
Tumour pain
6%
General physical health deterioration
6%
Hyperbilirubinaemia
6%
Tachycardia
6%
Dyspepsia
6%
Activated partial thromboplastin time prolonged
6%
Hypocalcaemia
6%
Hyperuricaemia
6%
Nasal congestion
6%
Urinary tract infection
6%
Hot flush
5%
Pulmonary embolism
5%
Upper respiratory tract infection
5%
Blood creatine phosphokinase increased
5%
International normalised ratio increased
5%
Dehydration
5%
Arthralgia
5%
Syncope
5%
Flank pain
5%
Memory impairment
5%
Dyspnoea exertional
5%
Dry mouth
5%
Pleural effusion
5%
Proteinuria
4%
Small intestinal obstruction
3%
Non-cardiac chest pain
3%
Small intestine obstruction
3%
Intestinal obstruction
3%
Acute kidney injury
3%
Deep vein thrombosis
3%
Cataract
3%
Sinusitis
3%
Hypochloraemia
3%
Insomnia
2%
Complication associated with device
2%
Respiratory failure
2%
Confusional state
2%
Hydronephrosis
2%
Ejection fraction decreased
2%
Pneumonia
2%
Chronic obstructive pulmonary disease
2%
Cellulitis
2%
Respiratory syncytial virus infection
2%
Facial bones fracture
2%
Visual Impairement
2%
Malaise
2%
Hypomagnesaemia
2%
Cerebral ischaemia
2%
Rectal haemorrhage
2%
Ileus
2%
Sepsis
2%
Bronchitis
2%
Embolism
2%
Bile duct obstruction
2%
Photopsia
2%
Vitreous floaters
2%
Abdominal distension
2%
Flatulence
2%
Chills
2%
Myalgia
2%
Muscle spasms
2%
Sciatica
2%
Epistaxis
2%
Oropharyngeal pain
2%
Haematuria
2%
Hypokalaemia
2%
Blood lactate dehydrogenase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 3 Open-label: Selinexor
Phase 2 Open-label: Selinexor
Phase 2 Double-blinded: Selinexor
Phase 2 Double-blinded: Placebo
Phase 3 Double-blinded: Selinexor
Phase 3 Double-blinded: Placebo

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 3
~1670

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
847 Previous Clinical Trials
535,382 Total Patients Enrolled
11 Trials studying Multiple Myeloma
311 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,625 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,205 Patients Enrolled for Multiple Myeloma
Jodi LipofPrincipal InvestigatorUniversity of Rochester
~5 spots leftby Dec 2024
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