Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03850704
• Other study ID #: 2019EX023
• Status: No longer available

Study information

• Verified date: February 2019
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

Description:

Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)

• Aged 18 years and older

• Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan

Exclusion Criteria:

• Known hypersensitivity to selinexor or any excipients.

• Patient receiving any other investigational agent.

• Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).

• Known intolerance, hypersensitivity, or contraindication to glucocorticoids.

• Active graft versus host disease (after allogeneic stem cell transplantation).

• Active, unstable cardiovascular function:

• Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)

• Congestive heart failure of New York Heart Association Class = 3 or known leftventricular ejection fraction < 40%, or

• Myocardial infarction within 3 months prior to C1D1.

• Significant renal impairment with ongoing dialysis treatment

• Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.

• Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Selinexor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota