KPD Consolidation After ASCT in NDMM Patients

Korábbi kezelés

• Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with any type of non-melanoma skin cancer or completely resected carcinoma in situ);
• Patients with concurrent or suspected central nervous system infiltration;

Más betegség

• Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
• Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia/ hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the CNS;
• Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;
• Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;
• Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;
• Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;
• Any other conditions deemed by the investigator as unsuitable for enrollment.

Egyéb

• Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
• Pregnant or lactating women;

• Age ≥18 years.
• Newly diagnosed MM eligible for transplantation.
• Received upfront triplet or quadraplet induction regimen.
• Received upfront ASCT after induction.
• ECOG score < 2.
• Adequate Organ Function Reserve:
  • Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
  • Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
  • Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
  • Basal oxygen saturation > 95% in room air;
• Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;
• The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.