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Corticosteroid

Selinexor for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Rachid Baz, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. ECOG 2 allowed if due to bone disease

Must have an echocardiogram or multigated acquisition (MUGA) scan indicating left ventricular ejection fraction (LVEF) ≥ 50% within 42 days prior to first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs for patients with relapsed or refractory myeloma. The goal is to find the best doses of the drugs and to see if the combination is effective.

Eligible Conditions

Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Maximum Tolerated Dose (MTD)

Overall Response Rate (ORR) - All Participants

Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose

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, Liposomal Doxorubicin and DexamethasoneExperimental Treatment3 Interventions

Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D). After the initial screening visit and registration in the study, participants will receive Selinexor orally at a dose of 80 mg along with dexamethasone for 1 day. One week later, patients will receive weekly selinexor at a starting dose from 60 mg once a week to 80 mg twice a week in combination with pegylated liposomal doxorubicin at a starting dose of 20 mg/m², and dexamethasone 40 mg orally weekly.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal doxorubicin

2010

Completed Phase 2

~910

Dexamethasone

2007

Completed Phase 4

~2590

Selinexor

2020

Completed Phase 2

~1360

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,464 Total Patients Enrolled

29 Trials studying Multiple Myeloma

2,085 Patients Enrolled for Multiple Myeloma

Karyopharm Therapeutics IncIndustry Sponsor

87 Previous Clinical Trials

7,551 Total Patients Enrolled

22 Trials studying Multiple Myeloma

2,192 Patients Enrolled for Multiple Myeloma

Rachid Baz, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

3 Previous Clinical Trials

164 Total Patients Enrolled

3 Trials studying Multiple Myeloma

164 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 are the primary conditions that Selinexor is used to treat?

"Selinexor is most often used to treat synovitis, though it can also be effective in treating ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema."

Answered by AI

Could you tell me how many individuals are taking part in this research project?

"Unfortunately, this clinical trial is not enrolling patients at the moment. However, there are 826 other trials concerning multiple myeloma and 933 studies involving Selinexor that are presently looking for participants."

Answered by AI

What other medical research has been done on Selinexor in the past?

"Selinexor was first trialled in 1997 at Spectrum Health Hospital - Butterworth Campus. There have been a total of 1720 completed clinical trials since then. There are 933 live trials as of now, with a large portion of these taking place in Tampa, Florida."

Answered by AI

Are investigators still looking for people to join this research project?

"Although this specific trial is not currently looking for patients, the most recent update on clinicaltrials.gov (from July 26th, 2022) indicates that it was originally posted on September 23rd, 2014. Additionally, there are 1759 other medical trials that are actively recruiting patients."

Answered by AI

Recent research and studies

Journal of Hematology & OncologyJournal

Treatment of Acquired Drug Resistance in Multiple Myeloma by Combination Therapy with XPO1 and Topoisomerase II Inhibitors

Turner, Joel G., Jana L. Dawson, Steven Grant, Kenneth H. Shain, William S. Dalton, Yun Dai, Mark Meads, et al.. 2016. “Treatment of Acquired Drug Resistance in Multiple Myeloma by Combination Therapy with XPO1 and Topoisomerase II Inhibitors”. Journal of Hematology & Oncology. Springer Science and Business Media LLC. doi:10.1186/s13045-016-0304-z.

clinicaltrials.govStudy

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

2014. "Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02186834.