A Phase 2, Open-Label Study of Ixazomib + Daratumumab + Dexamethasone (IDd) in Relapsedand/or Refractory Multiple Myeloma (RRMM)

Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited0 个研究点目标入组 60 人开始时间: 2018年5月17日最近更新: 2023年8月28日

试验速览

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•Adult patients (aged =18 years) who have been diagnosed with MM according to IMWG criteria
•? All patients must have measurable disease by at least 1 of the following measurements:
•o Serum M-protein =1 g/dL (=10 g/L).
•o Urine M-protein =200 mg/24 hours.
•? All patients must have documented evidence of PD on or after their last regimen as defined by IMWG criteria. All
•patients must have received between 1 to 3 prior therapies for MM.
•? All patients must have achieved a response (partial response [PR] or better) to at least 1 prior therapy.
•? All patients must have an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
•? All patients must have adequate hematologic, hepatic, and renal function.
•*Full details in Section 7.0.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•?Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
•? Patients have undergone prior allogenic bone marrow transplantation.
•? Patients have received prior ixazomib at any time or daratumumab or other anti-CD38 therapies except as part of initial therapy if this was stopped to move on to stem cell transplant (SCT) and the patient did not progress on anti-CD38 treatment.
•? Patients are refractory to bortezomib or carfilzomib at the last exposure before this study (defined as patient
•having PD while receiving bortezomib or carfilzomib therapy or within 60 days after ending bortezomib therapy).
•? Patients planning to undergo a SCT prior to PD on this study (ie, these patients should not be enrolled in order to
•reduce disease burden prior to transplant).
•? Patients with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral
•neuropathy or any grade neuropathy with pain; excluding alopecia).
•? Patient has any concurrent medical condition or disease that is likely to interfere with study procedures, results, or
•assessment of safety or toxicity or that in the opinion of the investigator would constitute a hazard for
•participating in this study.
•*Full details in Section 7.0.

发起方

Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited