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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
72%
Weight Decreased
68%
Nausea
60%
Fatigue
56%
Anaemia
52%
Thrombocytopenia
48%
Decreased Appetite
44%
Dysgeusia
44%
Vomiting
24%
Dyspnoea
24%
Diarrhoea
24%
Dizziness
24%
Constipation
20%
Asthenia
20%
Insomnia
20%
Vision Blurred
16%
Pyrexia
16%
Dysuria
16%
Back Pain
16%
Pollakiuria
12%
Hypokalaemia
12%
Headache
12%
Peripheral Sensory Neuropathy
12%
Cough
12%
Haematuria
12%
Nasopharyngitis
12%
Abdominal Pain
12%
Musculoskeletal Chest Pain
12%
Hypomagnesaemia
12%
Anxiety
8%
Arthralgia
8%
Confusional State
8%
Hallucination
8%
Malaise
8%
Device Occlusion
8%
Oedema Peripheral
8%
Urinary Tract Infection
8%
Depression
8%
Abdominal Distension
8%
Abdominal Pain Upper
8%
Face Oedema
8%
Hyponatraemia
8%
Paraesthesia
8%
Night Sweats
8%
Hot Flush
8%
Vaginal Haemorrhage
4%
Haematemesis
4%
Visual Impairment
4%
Muscular Weakness
4%
Ear Discomfort
4%
Anal Haemorrhage
4%
Rectal Haemorrhage
4%
Urinary Retention
4%
Vertigo
4%
Renal Failure
4%
Lung Infection
4%
Dyspepsia
4%
Cystitis Noninfective
4%
Stomatitis
4%
Dry Mouth
4%
Hyperglycaemia
4%
Hyperkalaemia
4%
Bronchitis
4%
Pulmonary Embolism
4%
Hypertension
4%
Bacteraemia
4%
Cystitis
4%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort B-Endometrial 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 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
1,059 Previous Clinical Trials
1,316,139 Total Patients Enrolled
18 Trials studying Multiple Myeloma
767 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,635 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
~1 spots leftby Jun 2025
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