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)

  • STATUS
    Recruiting
  • End date
    Oct 15, 2024
  • participants needed
    150
  • sponsor
    Antengene Corporation
Updated on 6 October 2021

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).

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).

Details
Condition Relapsed or Refractory Multiple Myeloma
Treatment ATG-010
Clinical Study IdentifierNCT04939142
SponsorAntengene Corporation
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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