NL-OMON54594招募中3 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 Myeloma - 68284528MMY3002/ CARTITUDE-4
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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 99（—）
入选标准
- •- Have documented diagnosis of Multiple myeloma diagnosis according to the IMWG
- •diagnostic criteria
- •- Measurable disease at screening as defined by any of the following:
- •* Serum monoclonal paraprotein (M-protein) level >=0.5 g/dL or urine M-protein
- •level >=200 mg/24 hours; or
- •* Light chain MM without measurable M-protein in the serum or the urine: Serum
- •free light chain >=10 mg/dL and abnormal serum free light chain ratio.
- •- 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
- •- PD per IMWG criteria <=6 months of last.
- •- 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 ((failure to
- •achieve minimal response or progression on or within 60 days of completing
- •lenalidomide therapy). Progression on or within 60 days of the last dose of
- •lenalidomide given as maintenance will meet this criterion. For subjects with
- •more than 1 prior line of therapy, there is no requirement to be lenalidomide
- •refractory to the most recent line of prior therapy. However, participants must
- •be refractory to lenalidomide in at least one prior line.
- •- Have an ECOG Performance Status score of 0 or 1
- •- Have clinical laboratory values as specified in the protocol.
- •- Women of childbearing potential must have 2 negative pregnancy tests before
- •start treatment
- •- When a woman is of childbearing potential, the subject must commit either to
- •continuously from heterosexual intercourse or agree to use 2 methods of
- •reliable birth
- •control simultaneously.
- •- A man who is sexually active with a woman of childbearing potential or a
- •woman must agree to use a barrier method of contraception (condom)
- •- Women and men must agree not to donate eggs or sperm, respectively, during
- •the study and for at least 3 months after receiving the last dose of
- •daratumumab or bortezomib, or 28 days after the last dose of pomalidomide,
- •whichever is later (Arm A) or at least 1 year after receiving a JNJ-68284528
- •infusion or at least 3 months after receiving the last dose of daratumumab or
- •bortezomib or 28 days after the last dose of pomalidomide, whichever is later
- •For additional information see section 5.1 of the protocol
排除标准
- •- Prior treatment with CAR-T therapy directed at any target.
- •- 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 Grade 1 peripheral neuropathy with pain or Grade 2 or higher
- •peripheral neuropathy will not be permitted to receive PVd as standard therapy
- •or bridging therapy; however, subject may receive DPd as standard therapy or
- •bridging therapy.
- •- Was vaccinated with live attenuated vaccines within 4 weeks prior to
- •randomization
- •- Subject received any antitumor therapy as specified in the protocol, prior to
- •randomization
- •- Active malignancies (ie, progressing or requiring treatment change in the last
- •24 months) 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.
- •- 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 graft-versus-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
研究者
相似试验
进行中（未招募）
1 期
A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaCTIS2023-506588-32-00Janssen - Cilag International397
进行中（未招募）
1 期
A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaRelapsed and lenalidomide-refractory multiple myeloma (MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2019-001413-16-BEJanssen-Cilag International NV400
进行中（未招募）
1 期
A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaEUCTR2019-001413-16-PLJanssen-Cilag International NV400
进行中（未招募）
1 期
A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaRelapsed and lenalidomide-refractory multiple myeloma (MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2019-001413-16-ITJANSSEN CILAG INTERNATIONAL NV400
进行中（未招募）
1 期
A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple MyelomaEUCTR2019-001413-16-GBJanssen-Cilag International NV400