A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation - N/A

ovartis0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Inclusion criteria
•1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
•2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)
•3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, stem cell transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.
•4. Presence of measurable disease as defined by at least one of the following;
•* Serum M-protein * 1g/dL (measurable disease)
•* Urine M-protein * 200mg/24 hours by protein electrophoresis (measurable disease)
•For a complete list of all Inclusion criteria, please refer to Section 5.1 of the protocol, page 36-37.

•Exclusion criteria
•1. Patients with non-secretory, or oligosecretory, multiple myeloma.
•2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
•3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
•For a complete list of all Exclusion criteria, please refer to Section 5.2 of the protocol, page 37-38.

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