A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma (MM)
To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
• Age ≥ 18 years.
• Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g/L; or urinary M protein level ≥ 200 mg/24 hours; or serum immunoglobulin free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio.
• Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a \<25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.
• ECOG assessment of 0, 1, or 2.
• Life expectancy of at least 3 months.
• The patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF).