A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04939142 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: ATG-010-MM-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 33

Brief Summary

This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  To evaluate progression-free survival

  Three years after last patient first dose

Secondary Outcomes (7)

• Overall Survival (OS)

  Three years after last patient first dose

• Duration of Response (DOR)

  Three years after last patient first dose

• Objective response rate (ORR)

  Three years after last patient first dose

• Progression-free survival(PFS2)

  Three years after last patient first dose

• Time to remission(TTR)

  Three years after last patient first dose

Study Arms (2)

SVd (Selinexor+Bortezomib+dexamethasone)

EXPERIMENTAL

Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.

Combination Product: SVd (Selinexor+Bortezomib+dexamethasone)

Vd(Bortezomib+dexamethasone)

EXPERIMENTAL

Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.

Combination Product: Vd (Bortezomib+dexamethasone)

Interventions

SVd (Selinexor+Bortezomib+dexamethasone) COMBINATION_PRODUCT

Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)

SVd (Selinexor+Bortezomib+dexamethasone)

Vd (Bortezomib+dexamethasone) COMBINATION_PRODUCT

Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])

Vd(Bortezomib+dexamethasone)

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form (ICF).
• Age ≥ 18 years.
• Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following:
• Serum M-protein ≥ 0.5 g/dL (\> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin IgA, IgD myeloma, replaced by quantitative serum IgA, IgD levels; or
• Urinary M-protein level ≥ 200 mg/24 hours; or
• Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal (Normal FLC ratio: 0.26 to 1.65).
• Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
• Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen.
• Must have an ECOG Status score of 0, 1, or 2.
• Renal function should meet the following criteria: creatinine clearance \[CrCl\] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault).
• Resolution of any clinically significant non-hematological toxicities (If any) from previous treatments to Grade ≤1 or baseline by C1D1. Subject with chronic, stable Grade 2 non hematological toxicities may be included following approval from the Medical Monitor.
• Female subjects of childbearing potential must have a negative serum pregnancy test at Screening. Female subjects of childbearing potential and fertile male subjects must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

You may not qualify if:

• Prior exposure to SINE compounds (Including ATG-010), or suspected allergy to SINE or similar drugs.
• Active plasma cell leukemia.
• Documented systemic light chain amyloidosis.
• MM involving the central nervous system.
• POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes).
• Spinal cord compression related to MM.
• Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication.
• Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
• Active graft versus host disease (After allogeneic stem cell transplantation) at screening.
• Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1.
• Major surgery within 4 weeks prior to C1D1.
• Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
• Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus deoxyribonucleic acid (HBV-DNA).
• Pregnant or lactating women.
• Life expectancy of \< 4 months.

Sponsors & Collaborators

• Antengene Corporation: lead

Study Sites (33)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

The First Affiliated Hospital OF USTC

Hefei, Anhui, 230031, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100043, China

Location

Peking University People'S Hospital

Beijing, Beijing Municipality, 100044, China

Location

Xinqiao Hospital Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Shenzhen Second People'S Hospital

Shenzhen, Guangdong, 518035, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Affiliated Hospital of Nantong University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Nanchang

Nanchang, Jiangxi, 330006, China

Location

Shengjing Hospital China Medical University

Shenyang, Liaoning, 110004, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, v, China

Location

Qilu Hospital of Shangdong University

Jinan, Shangdong, 250012, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 09022836, China

Location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

Shanghai, Shanghai Municipality, 200233, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital Zhejiang University of Medicine

Hangzhou, Zhejiang, 310016, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310003, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

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

Study Officials

• Jin Lu, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: July 12, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CN (33)