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ATG-010(Selinexor) in Combination With Chemotherapy in RRMM

NCT04877275 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-06

No results posted yet for this study

Summary

This is a single-arm that includes two experimental arms,Selinexor(ATG-010) in Combination with Chemotherapy to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of ATG-010 in combination with chemotherapy in RRMM patients received at least one prior lines of therapy

Conditions

Interventions

DRUG

Selinexor (80mg/d)

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. Arm I：80mg/d QW ;

DRUG

Selinexor (100mg/d)

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. Arm II：100mg/d QW ;

DRUG

Pegylated liposomal doxorubicin

25 mg/m\^2 intravenously on day 1 , QW

DRUG

Dexamethasone

Dexamethasone 40mg/d QW

DRUG

Cyclophosphamide

Cyclophosphamide：300mg/m2, d1 QW，

Sponsors & Collaborators

  • Chunyan Sun, MD

    lead OTHER

Principal Investigators

  • Chunyan Sun, M.D., Ph.D · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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
2021-05-21
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT04877275 on ClinicalTrials.gov