A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as Monotherapy and in Combination with Standard Therapy in Subjects with Relapsed/Refractory Multiple Myeloma

MorphoSys AG0 个研究点目标入组 91 人开始时间: 2011年7月12日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•1. Male or female subjects 18 years and older
•2. Relapsed or refractory multiple myeloma defined as failure of at least 2 previous therapies, at least 1 previosus failed therpapy for the LEN arm
•3. Presence of serum M-protein = 0.5 g per 100 mL (= 5 g/L) and / or urine M-protein = 200 mg/24-h
•4. ANC = 1.0 (1,000 / mm3)
•5. Haemoglobin = 8 g/dL
•6. Ability to comply with all study related procedures, medication use and evaluations

•Exclusion Criteria:
•1. Primary refractory multiple myeloma
•2. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
•3. Treatment with systemic investigational agent within 28 days prior to treatment start
•4. Solitary plasmocytoma or plasma cell leukaemia
•5. Previous allogenic SCT
•6. Prior therapy with other monoclonal antibodies targeting the CD38 antigen and prior therapy with other IgG monoclonal antibodies within 3 months prior to screening and IgM monoclonal antibodies within 1 month prior to treatment start
•7. Active systemic infection
•8. Systemic disease preventing study treatment
•9. Multiple myeloma with CNS involment
•10. Active treatment / chemotherapy for other primary malignancy within past 3 years, 5 years for the POM or LEN arm
•11. Significant uncontrolled cardiovascular disease or cardiac insufficiency

发起方