NCT04939142 · REGISTRY CONDITION SEARCH

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)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2026-08-10

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Objective Response Rate (ORR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form (ICF). 2. Age ≥ 18 years. 3. Confirmed MM with measurable disease per IMWG guidelines, and meet at least 1 of the following: 1. 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 2. Urinary M-protein level ≥ 200 mg/24 hours; or 3. Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal (Normal FLC ratio: 0.26 to 1.65). 4. 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. 5. Valid evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their last regimen. 6. Must have an ECOG Status score of 0, 1, or 2. 7. Renal function should meet the following criteria: creatinine clearance \[CrCl\] rates ≥ 20 mL/min (Calculated using the formula of Cockroft and Gault). 8. 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. 9. 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. Exclusion Criteria: 1. Prior exposure to SINE compounds (Including ATG-010), or suspected allergy to SINE or similar drugs. 2. Active plasma cell leukemia. 3. Documented systemic light chain amyloidosis. 4. MM involving the central nervous system. 5. POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes). 6. Spinal cord compression related to MM. 7. Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication. 8. Known intolerance, hypersensitivity, or contraindication to glucocorticoids. 9. Active graft versus host disease (After allogeneic stem cell transplantation) at screening. 10. Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1. 11. Major surgery within 4 weeks prior to C1D1. 12. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity. 13. 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). 14. Pregnant or lactating women. 15. Life expectancy of \< 4 months. 16. 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. 17. 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. 18. Contraindication to any of the required concomitant drugs or supportive treatments. 19. Any diseases or complications which may interfere with the study procedures. 20. Subject unwilling or unable to comply with the protocol.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Combination Product: SVd (Selinexor+Bortezomib+dexamethasone)
label
SVd (Selinexor+Bortezomib+dexamethasone)
type
EXPERIMENTAL
description
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
intervention Names
Combination Product: Vd (Bortezomib+dexamethasone)
label
Vd(Bortezomib+dexamethasone)
type
EXPERIMENTAL

interventions

arm Group Labels
SVd (Selinexor+Bortezomib+dexamethasone)
description
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)
name
SVd (Selinexor+Bortezomib+dexamethasone)
type
COMBINATION_PRODUCT
arm Group Labels
Vd(Bortezomib+dexamethasone)
description
Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
name
Vd (Bortezomib+dexamethasone)
type
COMBINATION_PRODUCT

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 154
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To evaluate progression-free survival
measure
Progression-Free Survival (PFS)
time Frame
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

description
evaluated by IRC (PR + VGPR + CR + sCR)
measure
Objective Response Rate (ORR)
time Frame
From randomization until the earlier of IRC-confirmed PD or start of subsequent anti-myeloma therapy, assessed up to 2 years.

Full study description

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).
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).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Independent clinical review pending · Not medical advice