Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Korábbi kezelés

• Received any prior B cell maturation antigen (BCMA)-targeted therapy.
• Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before randomization.
• Received a live, attenuated vaccine within 4 weeks before randomization.
• Contraindication, intolerance, or life-threatening allergy to any investigational product or excipient.

Más betegség

• IMWG-defined disease refractory to anti-CD38 therapy.
• Participants are not eligible to receive DPd as control therapy if any of the following are present: Contraindication, life-threatening hypersensitivity, or intolerance to pomalidomide.
• Participants with primary light-chain amyloidosis (AL), plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or solitary plasmacytoma.

• Signed informed consent form.
• Age ≥18 years. Gender is not limited.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
• Participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug.
• Investigator-assessed evidence of disease progression or failure to achieve response after the last line of therapy, according to the International Myeloma Working Group (2016IMWG) criteria.
• Measurable disease at screening, defined by at least one of the following:
  • Serum M-protein≥5 g/L;
  • Urine M-protein≥200 mg/24 h;
  • Involved serum FLC level≥100 mg/L with an abnormal κ/λ ratio.