JPRN-jRCT2051230065招募中1 期
A Phase 1/2 open-label, multicentre, dose escalation and expansion study to investigate the safety, tolerability, and clinical activity of belantamab as monotherapy and in combination with other treatments in participants with multiple myeloma - DREAMM-20
Ishibashi Hideyasu0 个研究点目标入组 124 人开始时间: 2023年7月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
- •-Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG, and measurable disease.
- •-PART 1: Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable). Lines of therapy are defined by consensus panel of the International Myeloma Workshop.
- •-PART 2: Participants who meet all of the following:
- •Have undergone Autologous stem cell transplant (ASCT) or are considered transplant ineligible
- •Have been previously treated with at least ONE prior line of MM therapy
- •Have documented disease progression during or after their most recent therapy
- •-PART 3: Participants who meet both of the following:
- •-NDMM with a requirement for treatment as documented per IMWG criteria
- •-Not considered a candidate for high dose chemotherapy with ASCT due to:
- •Age >- 65 years OR
- •Age 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT or who refuse high-dose chemotherapy with ASCT as an initial treatment.
- •-Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.
排除标准
- •-Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
- •-Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
- •-Active infection requiring antibiotic, antiviral, or antifungal treatment.
- •-Known, current drug or alcohol abuse.
- •-Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.
研究者
相似试验
进行中（未招募）
1 期
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101)MedDRA version: 21.1Level: PTClassification code: 10062194Term: Metastasis Class: 100000004864CancerCTIS2023-508422-95-00Synthorx Inc.294
进行中（未招募）
1 期
A study to investigate the use of the study drug NKTR-214 in combination with other approved treatments for solid tumours.ocally Advanced or Metastatic Solid Tumor MalignanciesMedDRA version: 20.0Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2016-003543-11-ESektar Therapeutics290
进行中（未招募）
1 期
A study to investigate the use of the study drug NKTR-214 in combination with other approved treatments for solid tumours.EUCTR2016-003543-11-FRektar Therapeutics290
撤回
不适用
A Phase 1/2, open-label, multicenter, dose escalation and dose expansion study of SAR442720 in combination with other agents in participants with advanced malignanciesmetastatic non small cell lungcancermetastatic lung cancer10029107NL-OMON51317Genzyme Europe BV5
进行中（未招募）
1 期
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients with Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple Myeloma (RRMM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2019-004793-26-DEHarpoon Therapeutics, Inc.114