EUCTR2018-000386-36-IT进行中（未招募）1 期
A Pilot study on the efficacy of Daratumumab in Multiple Myeloma (MM) patients in >VGPR/MRD-positive by next generation flow (NGF) - DART4MM
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE0 个研究点目标入组 50 人开始时间: 2021年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-85 years at the time of signing the informed consent form
- •Able to adhere to the study visit schedule and other protocol requirements
- •>VGPR/MRD-positive by NGF measured by 2-tubes optimized 8-color antibody panel, (OneFlow PCST e PCD BD Biosciences)
- •At least 12 weeks from any therapy for myeloma
- •Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
- •Laboratory values and electrocardiogram within protocol-defined parameters at screening
- •All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy.
- •Laboratory test results within these ranges:
- •Absolute neutrophil count greater / equal 1.0 x 109/L
- •Platelet count greater / equal 75 x 109/L
- •Creatinine clearance > 30 ml/h)
- •Total bilirubin less than / equal 1.5 mg/Dl
- •Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) less than / equal 2 x ULN
- •Disease free of prior malignancies for greater / equal 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •Fertile patients must use effective contraception during and for 6 months after study treatment
- •Patients must sign on an Informed Consent Form
- •No study treatment or any other procedure within the framework of the trial (except for screening) will be performed in any patient prior to receipt of written informed consent.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Received daratumumab or other anti-CD38 therapies previously
- •Nonsecretory multiple myeloma
- •Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
- •Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
- •Absence of the Informed Consent Form signed by the patient
- •Pregnant or breast feeding females
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to the study drugs
- •Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C.
- •Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisEUCTR2021-002639-48-ESJanssen-Cilag International N.V.150
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisEUCTR2021-002639-48-NLJanssen-Cilag International N.V.150
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisCTIS2023-507069-25-00Janssen - Cilag International190
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisAmyloid Light Chain AmyloidosisMedDRA version: 23.0Level: LLTClassification code 10083938Term: Amyloid light-chain amyloidosisSystem Organ Class: 100000004870EUCTR2021-002639-48-DEJanssen-Cilag International N.V.150
招募中
2 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisNL-OMON51367Janssen-Cilag International NV12