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Macrolide Antibiotic

Selinexor for Multiple Myeloma (ClaSPd Trial)

Phase 2
Waitlist Available
Led By Jorge Monge, MD
Research Sponsored by Weill Medical College of Cornell University
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 adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. the maximum period that aes were collected for a participant was 300 days.
Awards & highlights

ClaSPd Trial Summary

This trial is testing a new combination therapy for patients with relapsed or refractory multiple myeloma. The hypothesis is that the addition of the drug Selinexor will increase the overall response rate.

Eligible Conditions
  • Multiple Myeloma

ClaSPd Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. the maximum period that aes were collected for a participant was 300 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. the maximum period that aes were collected for a participant was 300 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Overall Response Rate of Partial Response or Better
Secondary outcome measures
Number of Participants With Adverse Events

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

ClaSPd Trial Design

1Treatment groups
Experimental Treatment
Group I: Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)Experimental Treatment4 Interventions
Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Clarithromycin
2017
Completed Phase 4
~3950
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,524 Total Patients Enrolled
18 Trials studying Multiple Myeloma
767 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,575 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,216 Patients Enrolled for Multiple Myeloma
Jorge Monge, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Multiple Myeloma
12 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.

Are there any remaining slots available for participants in this trial?

"As per the information reported on clinicaltrials.gov, this medical trial is in search of participants. It was initially posted in late December 2021 and amended as recently as mid-January 2022."

Answered by AI

How many participants is this experiment recruiting?

"Affirmative, the information observed on clinicaltrials.gov reveals that this research is presently in need of subjects. This project was first advertised to the public on December 29th 2021 and has been revised as recently as January 20th 2022. The study calls for 26 participants divided among three distinct sites."

Answered by AI

Has Selinexor previously been subjected to scientific evaluation?

"The Manitoba Blood & Marrow Transplant Program CancerCare Manitoba began studying selinexor in 2002 and has since completed over 1,000 research trials. At the moment 623 studies are actively recruiting patients with a large portion of these being conducted out of Brooklyn, New york."

Answered by AI

What conditions does Selinexor typically address?

"Traditionally, selinexor has been prescribed as a therapy for ophthalmia and sympathetic. However, it is also known to be an effective remedy for branch retinal vein occlusion, macular edema, communicable diseases."

Answered by AI

What characteristics make an individual a suitable candidate for this trial?

"Patients must meet the criteria of 18-74 years old and be diagnosed with multiple myeloma to join this trial. The aim is to enrol 26 individuals in the study."

Answered by AI

To what extent does Selinexor present potential harm to patients?

"Selinexor has been assigned a safety rating of 2 on our scale, as there is limited data confirming its efficacy but some evidence backing up its security."

Answered by AI

Does this trial permit geriatric individuals to participate?

"This research aims to recruit patients who are in the 18-74 year old age bracket."

Answered by AI
~1 spots leftby Apr 2025