CTIS2023-506588-32-00进行中（未招募）1 期
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaCARTITUDE-4 - 68284528MMY3002
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 397
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Be at least 18 years of age., Have documented diagnosis of MM as defined by the criteria below:-Multiple myeloma diagnosis according to the IMWG diagnostic criteria -Measurable disease at screening, Have received 1 to 3 prior lines of therapy including a PI and IMiD. Subject must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy, Have documented evidence of PD by IMWG criteria based on investigator's determination on or within 6 months of their last regimen., Subjects with only 1 prior line of therapy must have progressed within 36 months of a stem cell transplant or if not transplanted, then within 42 months of starting initial therapy., Be refractory to lenalidomide per IMWG consensus guidelines in at least one prior line of therapy., Have an ECOG Performance Status score of 0 or 1, Have clinical laboratory values as specified in the protocol. For additional information see section 5.1 of the protocol
排除标准
- •Prior treatment with CAR-T therapy directed at any target., Stroke or seizure within 6 months of signing ICF., Received either of the following:-An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graftversus-host disease. Subjects with active graft-versus-host disease are excluded.-An autologous stem cell transplantation = 12 weeks before apheresis., Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. For additional information, see section 5.2 of the protocol, Any previous therapy that is targeted to BCMA., Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia., Subjects with ongoing peripheral neuropathy may be limited to DPd as standard therapy or bridging therapy, Was vaccinated with live attenuated vaccines within 6 weeks prior to randomization, Subject received any antitumor therapy as specified in the protocol, prior to randomization, Active malignancies other than the disease being treated under study. Refer to the protocol for allowed exceptions., Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis., Contraindications or life-threatening allergies, hypersensitivity, or intolerance to JNJ 68284528 or its excipients, including dimethylsulfoxide, or to fludarabine, cyclophosphamide, tocilizumab, pomalidomide, dexamethasone.- Subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to daratumumab will not be permitted to receive DPd as standard therapy or bridging therapy; however, subjects may receive PVd as standard therapy or bridging therapy. Likewise, subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib will not be permitted to receive PVd as standard therapy or bridging therapy; but may receive DPd as standard therapy or bridging therapy.
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