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Selinexor in Combination With Immunomodulator （Thalidomide/Pomalidomide/Lenalidomide）in RRMM

NCT04941937 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-27

No results posted yet for this study

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 three arms, Selinexor(ATG-010) in Combination with Immunomodulator (Thalidomide/ Pomalidomide/ Lenalidomide）and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients. To evaluate efficacy and safety of Selinexor in combination with Immunomodulator and Dexamethasone in RRMM patients received at least one prior lines of therapy.

Conditions

Interventions

DRUG

Selinexor

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. Selinexor 60mg/d QW

DRUG

Thalidomide

100mg/d, Po. on day1-28

DRUG

Lenalidomide

PO,Lenalidomide 25mg once daily from D1-21

DRUG

Pomalidomide

Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle, PO.

DRUG

Dexamethasone

Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).

Sponsors & Collaborators

  • Juan Du

    lead OTHER

Principal Investigators

  • Juan Du, M.D., Ph.D · Shanghai Changzheng Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941937 on ClinicalTrials.gov