Selinexor Treatment for Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy.
NCT04519476 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2023-10-31
Summary
This is a pilot study evaluating the safety and efficacy of selinexor among multiple myeloma (MM) patients that are refractory to lenalidomide-containing regimens with or without steroids.
Conditions
- Refractory Multiple Myeloma
Interventions
- DRUG
-
Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
- DRUG
-
Immunomodulatory drug
- DRUG
-
Methylprednisolone
Glucocorticoid, steroid
Sponsors & Collaborators
-
Karyopharm Therapeutics Inc
collaborator INDUSTRY -
Oncotherapeutics
lead INDUSTRY
Principal Investigators
-
James R Berenson, MD · Oncotherapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-01
- Primary Completion
- 2023-12-29
- Completion
- 2023-12-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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