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Relapsed or Refractory Multiple MyelomaPhase 3BENCHNCT04939142

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)

A Phase 3 study testing SVd (Selinexor+Bortezomib+dexamethasone) and Vd (Bortezomib+dexamethasone) in people with Relapsed or Refractory Multiple Myeloma, run by Antengene Corporation at 33 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
SVd (Selinexor+Bortezomib+dexamethasone) and Vd (Bortezomib+dexamethasone)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
33 sitesChina
Study dates
12 Jul 2021to 30 Oct 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Any active gastrointestinal dysfunction interfering with the subject's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
  • Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
  • Contraindication to any of the required concomitant drugs or supportive treatments.
  • Any diseases or complications which may interfere with the study procedures.
  • Subject unwilling or unable to comply with the protocol.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 100043

  • Peking University People'S Hospital

    Beijing, Beijing Municipality, 100044

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Xinqiao Hospital Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Guangdong Provincial People'S Hospital

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital Zhejiang University of Medicine

    Hangzhou, Zhejiang, 310016

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The First Affiliated Hospital OF USTC

    Hefei, Anhui, 230031

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Qilu Hospital of Shangdong University

    Jinan, Shangdong, 250012

  • Affiliated Hospital of Nantong University

    Nanchang, Jiangxi, 330006

  • The First Hospital of Nanchang

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Qingdao Municipal Hospital

    Qingdao, Shandong, v

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 09022836

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai, Shanghai Municipality, 200233

  • Shengjing Hospital China Medical University

    Shenyang, Liaoning, 110004

  • Shenzhen Second People'S Hospital

    Shenzhen, Guangdong, 518035

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: 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)

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).

Read the detailed description

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). About 150 subjects are planned to be enrolled in this study, and be randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm).

Being tested
SVd (Selinexor+Bortezomib+dexamethasone), Vd (Bortezomib+dexamethasone)
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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])

Study groups in NCT04939142
Study groupRoleWhat they receive
SVd (Selinexor+Bortezomib+dexamethasone)ExperimentalEnrolled 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.
Receives: Combination Product: SVd (Selinexor+Bortezomib+dexamethasone)
Vd(Bortezomib+dexamethasone)ExperimentalEnrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
Receives: Combination Product: Vd (Bortezomib+dexamethasone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    To evaluate progression-free survival

    Measured: From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    evaluated by IRC (PR + VGPR + CR + sCR)

    Measured: From randomization until the earlier of IRC-confirmed PD or start of subsequent anti-myeloma therapy, assessed up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start12 Jul 2021
  3. Primary completion26 Aug 2024
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939142
Sponsor's protocol ID
ATG-010-MM-002
Acronym
BENCH
Status last verified
May 2026
First submitted
17 Jun 2021
Last updated
10 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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