Selinexor in Combination With Thalidomide and Dexamethasone in RRMM
NCT04891744 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2021-05-18
Summary
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This is a single-arm that includes escalation phase and expansion phase ,Selinexor in Combination withThalidomide and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of Selinexor in combination with Thalidomide and Dexamethasone in RRMM patients received at least one prior lines of therapy
Conditions
Interventions
- DRUG
-
Selinexor (ATG-010# 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
-
Thalidomide
100mg/d, Po. on day1-28
- DRUG
-
20 mg/d Po. on day 1, 2,8,9,15,16,22,23
Sponsors & Collaborators
-
Li Zheng
lead OTHER
Principal Investigators
-
Ting Niu, M.D., Ph.D · West China Hospital
-
Li Zheng, M.D., Ph.D · West China Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-06
- Primary Completion
- 2024-12-30
- Completion
- 2024-12-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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