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)

Korábbi kezelés

• Prior exposure to SINE compounds (Including ATG-010), or suspected allergy to SINE or similar drugs.
• Greater than Grade 2 peripheral neuropathy or Grade ≥ 2 peripheral neuropathy with pain at baseline, regardless of whether the subject is currently receiving medication.
• Uncontrolled active infections requiring intravenous antibiotics, antivirals, or antifungal therapy in 2 weeks prior to C1D1.
• Major surgery within 4 weeks prior to C1D1.
• Contraindication to any of the required concomitant drugs or supportive treatments.

Más betegség

• POEMS syndrome (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes).
• Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
• Active graft versus host disease (After allogeneic stem cell transplantation) at screening.
• 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).
• 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.
• Any diseases or complications which may interfere with the study procedures.

Egyéb

• Active plasma cell leukemia.
• Documented systemic light chain amyloidosis.
• MM involving the central nervous system.
• Spinal cord compression related to MM.
• 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.
• Subject unwilling or unable to comply with the protocol.

• 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.