Risk Stratification and MRD-driven Maintenance for MM After ASCT

Korábbi kezelés

• Must not have progressed on multiple myeloma (MM) therapy before screening
• History of stroke or serious thrombotic event within 12 months prior to screening.

Más betegség

• Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；

Egyéb

• Must not refractory or non-tolerate to lenalidomide in Arm A.
• Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
• Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification

• Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
• Must have a partial response (PR) or better response before maintenance.
• Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
• This study allows for post-ASCT consolidation therapy.
• ANC ≥ 1.0 x 10\^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10\^9/L (if BMPC < 50%) or PLT ≥ 50 x 10\^9/L (if BMPC ≥ 50%).
• No active infection.
• a).TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 45mL/min.