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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Multiple Myeloma

Phase 1

Recruiting

Led By James R Berenson, MD

Research Sponsored by Oncotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Study Summary

This trial is testing a new drug for people with a certain type of blood cancer who haven't responded well to other treatments.

Who is the study for?

This trial is for adults over 18 with multiple myeloma that's not responding to lenalidomide treatments. They must have measurable disease, be able to follow the study plan, and use effective birth control if applicable. Exclusions include uncontrolled infections, active HIV or hepatitis, recent major surgery, other serious health issues that could affect the study or consent process.Check my eligibility

What is being tested?

The trial tests selinexor's safety and effectiveness in treating multiple myeloma patients who haven't responded to lenalidomide-based therapy. It explores whether adding selinexor (with or without steroids) can help where previous treatment hasn't worked.See study design

What are the potential side effects?

Selinexor may cause nausea, vomiting, fatigue, loss of appetite and weight loss. There might also be blood count changes leading to anemia or increased risk of infection and possible liver or kidney function alterations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit Rate

Overall Response

Secondary outcome measures

Adverse Events Occurrences

Duration of Response (DOR)

Overall survival (OS)

+3 more

Other outcome measures

Measuring levels of multiple myeloma specific biomarkers such as M-Protein and BCMA

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: Selinexor/Lenalidomide/SteroidsExperimental Treatment3 Interventions

All subjects enrolled will receive: 1) selinexor, PO, at 60 mg once weekly on days 1-28 of a 28-day cycle, 2) lenalidomide, PO, 10 mg daily on days 1-21 of 28-days cycle and 3) methylprednisolone at the same dose and schedule as the last lenalidomide-containing regimen if it contained steroids. If patient's qualifying lenalidomide-containing regimen contained different type of steroid (e.g. prednisone, dexamethasone, etc.) then patient on this study will receive methylprednisolone at the equivalent dose and schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

Selinexor

2020

Completed Phase 2

~1360

Lenalidomide

2005

Completed Phase 3

~1480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Karyopharm Therapeutics IncIndustry Sponsor

87 Previous Clinical Trials

7,557 Total Patients Enrolled

22 Trials studying Multiple Myeloma

2,198 Patients Enrolled for Multiple Myeloma

OncotherapeuticsLead Sponsor

22 Previous Clinical Trials

921 Total Patients Enrolled

21 Trials studying Multiple Myeloma

898 Patients Enrolled for Multiple Myeloma

James R Berenson, MDPrincipal InvestigatorOncotherapeutics

8 Previous Clinical Trials

396 Total Patients Enrolled

8 Trials studying Multiple Myeloma

396 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

What medical maladies has Selinexor been proven to alleviate?

"Generally, selinexor is employed to treat ophthalmia and sympathetic. However, this medication has also been proven effective in managing scalp structure issues, ulcerative colitis, and for those who have had at least two past systemic chemotherapy regimens."

Answered by AI

What is the aim of this investigation?

"This trial is slated to conclude in about 2.5 years and its primary endpoint will be the Clinical Benefit Rate (CBR). Secondary metrics include Time to Progression, Overall Survival, and Adverse Events Occurrences that are judged using CTCAE v. 5.0 standards."

Answered by AI

Does this research endeavor currently have capacity for new participants?

"According to the information provided on clinicialtrials.gov, this medical trial is actively recruiting participants and has been since November 1st 2020. The most recent update was posted in April of 2022."

Answered by AI

What is the scope of participation for this clinical experiment?

"Yes, the information on clinicialtrials.gov confirms that this research is still searching for participants. This experiment was first shared on November 1st 2020 and has recently been updated as of April 18th 2022. The study requires a total of 22 individuals to be recruited from one site."

Answered by AI

Is Selinexor an innocuous treatment option?

"Our team at Power assigned Selinexor a safety rating of 1, due to the limited data available on its efficacy and security as this is currently in Phase 1."

Answered by AI

What precedent has been set by prior research involving Selinexor?

"Presently, 451 clinical trials into Selinexor are underway with 98 at the Phase 3 stage. Most of these studies are located in Duarte, California although there is a global presence among 19998 other sites investigating this treatment."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

First-in-class, First-in-human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients with Advanced Solid Tumors

Abdul Razak, Albiruni R., Morten Mau-Soerensen, Nashat Y. Gabrail, John F. Gerecitano, Anthony F. Shields, Thaddeus J. Unger, Jean R. Saint-Martin, et al.. 2016. “First-in-class, First-in-human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients with Advanced Solid Tumors”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.65.3949.

Journal of Clinical OncologyJournal

Phase IB Study of Selinexor, a First-in-class Inhibitor of Nuclear Export, in Patients with Advanced Refractory Bone or Soft Tissue Sarcoma

Gounder, Mrinal M., Alona Zer, William D. Tap, Samer Salah, Mark A. Dickson, Abha A. Gupta, Mary Louise Keohan, et al.. 2016. “Phase IB Study of Selinexor, a First-in-class Inhibitor of Nuclear Export, in Patients with Advanced Refractory Bone or Soft Tissue Sarcoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.67.6346.

Journal of Clinical OncologyJournal

Phase IB Study of Selinexor, a First-in-class Inhibitor of Nuclear Export, in Patients with Advanced Refractory Bone or Soft Tissue Sarcoma

clinicaltrials.govStudy

Selinexor Treatment for Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy.