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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Smoldering Multiple Myeloma

Q: 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.

Q: 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.

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

Our team at Power assesses the safety of <a href="https://www.withpower.com/clinical-trials/experimental">Experimental</a>: Treatment to be a 2, as there is some data that suggests it is safe but no evidence yet proving its efficacy.

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

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...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after end of treament

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

Ear Discomfort

Face Oedema

Oedema Peripheral

Pulmonary Embolism

Syncope

Cough

Confusional State

Auditory Disorder

General Physical Health Deterioration

Deep Vein Thrombosis

Urinary Tract Infection

Hyperglycaemia

Pain In Extremity

Hypotension

Paraesthesia

Infection

Visual Impairment

Insomnia

Pneumonia

Cataract

Varicella Zoster Virus Infection

Oropharyngeal Pain

Vertigo

Urosepsis

Pyrexia

Supraventricular Tachycardia

Femoral Neck Fracture

Depression

Polyurea

Hot Flush

Headache

Gait Disturbance

Abdominal Pain

Abdominal Distension

Stomatitis

Ascites

Dry Mouth

Abdominal Pain Lower

Oral Candidiasis

Arthralgia

Vaginal Haemorrhage

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

840 Previous Clinical Trials

534,235 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

Recent research and studies

clinicaltrials.govStudy

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Jodi Lipof 2023. "Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597345.