A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma

NCT03944057 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATG-010-MM-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 17

Brief Summary

This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors.

Conditions

Relapse/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria: * CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and \<5% plasma cells in bone marrow aspirates; * sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells); * VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; * PR means ≥50% reduction of serum M-protein plus reduction in 24-hour urine M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.

  12 months

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  12 months

Study Arms (1)

ATG-010 + Dexamethasone

EXPERIMENTAL

Open-label ATG-010 80mg plus Dexamethasone 20 mg

Drug: ATG-010

Interventions

ATG-010 DRUG

ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle). Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)

Also known as: Selinexor

ATG-010 + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent in accordance with federal, local, and institutional guidelines.
• Age ≥ 18 years at the time of signing informed consent.
• Patients must have previously received including proteasome inhibitors (PI) (i.e., lenalidomide) and immunomodulatory drugs (i.e., bortezomib) and were refractory to both drugs.
• Adequate hepatic function within 21 days prior to Cycle 1 Day 1: total bilirubin \< 2x upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3x ULN), AST \< 2.5x ULN and ALT \< 2.5x ULN.
• Adequate renal function within 21 days prior to Cycle 1 Day 1: estimated creatinine clearance of ≥ 20 mL/min, calculated using the formula of cockroft and gault.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• Measurable MM based on IMWG guidelines.
• Hemoglobin level ≥ 8.5 g/dL
• ANC ≥ 1000/mm\^3
• Platelet count ≥ 75,000/mm\^3 (patients in whom \< 50% of bone marrow nucleated cells are plasma cells) or ≥ 50,000/mm\^3 (patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells. \[Platelet transfusions \< 1 week prior to Cycle 1 Day 1 are prohibited (see below).\]
• Female subjects of child-bearing potential must have both of the following:
• Agree to the use of two study physician-approved contraceptive methods simultaneously, or practice complete abstinence starting at the time of ICF signature, while on study medication, and 3 months following the last dose of study drug.
• Have negative serum pregnancy test result at screening.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Active smoldering MM.
• Active plasma cell leukemia.
• Documented systemic amyloid light chain amyloidosis.
• Active central nervous system (CNS) MM.
• Pregnancy or breastfeeding.
• Chemotherapy ≤ 4 week, radiation and immunotherapy ≤ 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1.
• Active graft vs. host disease (after allogeneic stem cell transplantation) at Cycle 1 Day 1
• Life expectancy of \< 4 months.
• Major surgery within four weeks prior to Cycle 1 Day 1.
• Active, unstable cardiovascular function:
• Symptomatic ischemia, or
• Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or
• Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, or
• Myocardial infarction (MI) within 3 months prior to Cycle 1 Day 1.

Sponsors & Collaborators

• Antengene Corporation: lead

Study Sites (17)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510000, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Sun Yat-Sen University Cancer Center

Guanzhou, Guangdong, 510060, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

The Third Xiangya Hospital of Central Suoth University

Changsha, Hunan, 410013, China

Location

The First Affilate Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Shanghai Sixth People's Hospital Affiliate Shanghai JiaoTong University

Shanghai, Shanghai Municipality, 200233, China

Location

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Tianjin blood research institute

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Qiu L, Xia Z, Fu C, Chen W, Chang C, Fang B, An G, Wei Y, Cai Z, Gao S, Weng J, Chen L, Jing H, Li F, Liu Z, Chen X, Liu J, Wang A, Yu Y, Xiang W, Lynch K, Yu Z, Fu W. Selinexor plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma previously treated with an immunomodulatory agent and a proteasome inhibitor (MARCH): a phase II, single-arm study. BMC Med. 2022 Apr 5;20(1):108. doi: 10.1186/s12916-022-02305-4.

  PMID: 35379237 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Shimin Sun
• Organization: Antengene Corporation

jasmine.sun@antengene.com

+8613701803117

Study Officials

• Ying Jiao, MD

  Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 9, 2019
• Study Start: September 2, 2019
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Locations

CN (17)