CTIS2022-500138-27-01招募中1 期
A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study - 54767414MMY3030
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 176
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
- •Participants must: ? be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen R&D studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis, ? continue to benefit from study treatment, ? not have experienced disease progression or unmanageable toxicity while receiving daratumumab, ? not have met the withdrawal criteria set forth in the parent study, and ? have had the last dose of study treatment within the previous 3 months., Investigator’s assessment that the benefit of continued study treatment will outweigh the risks., A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study, A female participant must be either of the following: a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception throughout the study and through 3 months after the last dose of daratumumab., A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study for specified periods after the last dose of study treatment., A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for specified periods after the last dose of study treatment. If partner is a female of childbearing potential, the male participant must use condom with spermicide and the partner must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use contraception., A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment., Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study., Willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment., Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments., Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab IB and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)., Vaccinated with an investigational vaccine (except for COVID-19) or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment.
研究者
相似试验
已完成
2 期
A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) AmyloidosisLight Chain (AL) Amyloidosis, Stage 3BNCT04131309Stichting European Myeloma Network40
进行中（未招募）
1 期
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple MyelomaMultiple MyelomaEUCTR2021-003284-10-SEStichting European Myeloma Network (EMN)750
招募中
3 期
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant EligibleKahler's disease10035227Multiple MyelomaNL-OMON56455European Myeloma Network32
进行中（未招募）
1 期
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Multiple MyelomaEUCTR2021-003284-10-NOStichting European Myeloma Network (EMN)750
尚未招募
3 期
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myelomaewly Diagnosed Multiple MyelomaJPRN-jRCT2063220071onergan Sarah50