CTIS2024-514016-26-00进行中（未招募）1 期
An open label, multicenter, Phase 2, pilot study, evaluating early treatment with bispecific T-cell redirectors (teclistamab and talquetamab) in the frontline therapy of newly diagnosed high-risk multiple myeloma - GEM-TECTA
Fundacion Pethema0 个研究点目标入组 30 人开始时间: 2024年7月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements, A female of childbearing potential must have a negative highly sensitive urine or serum (ß human chorionic gonadotropin [ß hCG]) pregnancy test at screening and 24h prior to the start of study treatment and must agree to further urine or serum pregnancy tests during the study, A woman must be: a. Not of childbearing potential, or b. Of childbearing potential and i. Practicing true abstinence; or ii. Have a sole partner who is vasectomized; or iii. Practicing 2 methods of contraception (at least 1 highly-effective), A female patient must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study treatment, A male patient must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 3 months after receiving the last dose of study treatment. Male participants must also be advised of the benefit for a female partner to use a highly effective method of contraception as condoms may break or leak., A male patients 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., Patient must be willing and able to adhere to the lifestyle restrictions specified in the protocol (Section 4.3), All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 5.0 must be = Grade 1 at the time of enrolment except for alopecia., Patient has given voluntary written informed consent before performance of any study-related procedure nor part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care., Patient is = 18 years of age at the time of informed consent, Patient has documented diagnosis of multiple myeloma according to IMWG diagnostic criteria, with at least one of the following high-risk features: a)High-risk FISH: del(1p), del(17p), t(4;14), t(14;16) and 1q amplifications. b)R-ISS 3. c)Presence of extramedullary disease, defined as presence of paramedullary lesions or extramedullary plasmacytoma., Patient has measurable secretory disease defined as either serum monoclonal protein of = 0.5 g/dl or urine monoclonal (light chain) protein = 200 mg/24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be = 10mg/dL (100 mg/L), with an abnormal serum FLC ratio., Human inmunodeficiency virus-positive patients are elegible if the meet all of the following: a. No detectable viral load (ie, < 50 copies/mL) at screening b. CD4+ count > 300 cells/mm3 at screening c. No AIDS defining opportunistic infection within 6 months of screening d. Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening., Patients eligible for transplant with age =70 years old (young and transplant-eligible) or patients not eligible for transplant with ECOG-PS modified frailty score of 0-1., Patient has an ECOG performance status of 0, 1or 2., Patient must have adequate organ function, defined in: Hemoglobin = 8 g/dL, Platelets = 75 x 109/L in participa
排除标准
- •Prior or current systemic therapy or SCT for any plasma cell dyscrasia, with the exception of 1 cycle of antimyeloma treatment or the emergency use of a short course of corticosteroids before treatment while waiting for results of genetic analysis, Patient has CNS or exhibits clinical signs of meningeal involvement of MM, Patient is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment, Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment, Patient is simultaneously enrolled in other interventional CT, Patient has received prior radiotherapy within 2 weeks of start of study therapy. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (= 2 weeks of radiotherapy ) to non CNS disease, Prior or concurrent exposure to any of the following: -Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks -Live, attenuated vaccine within 4 weeks, before enrollment.Non-life vaccines authorized for emergency use (eg. COVID-19) and allowed (APPENDIX 22). - Monoclonal antibody therapy within 21 days (not use for the treatment of MM), Received a strong CYP3A4 inducer within 5 half-lives prior to starting study treatment, A maximum cumulative dose of corticosteroids of = 140 mg of prednisone or equivalent within 14 day period before the first dose of Tec-Dara or Tal-Dara, Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients, or sensitivity to mammalian-derived products or lenalidomide, Presence of the following cardiac conditions: a) New York Heart Association stage III or IV congestive heart failure (APPENDIX 19) b) Myocardial infarction or coronary artery bypass graft = 6 months prior to starting study treatment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities., Plasmapheresis within 28 days of starting study treatment defined as C1D1 of D-VRD., Stroke, transient ischemic attack or seizure within 6 months prior to signing ICF, Any of the following: -Hepatitis B infection (ie, HBsAg or HBV-DNA +). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status -Active hepatitis C infection as measured by + HCV-RNA testing. Patients with a history of HCV antibody + must undergo HCV-RNA testing. If a patient with history of chronic hepatitis C infection (HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the patient is eligible for the study, Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, COPD with a FEV1 < 50% of predicted normal. Note that FEV1 testing is required for patients with known or suspected of having COPD or asthma and patients must be excluded if FEV1 < 50% of predicted normal, Moderate or severe persistent asthma within t
研究者
相似试验
进行中（未招募）
不适用
An open label, multicenter, pilot phase II study of SOM230 s.c. in patients with duodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma, Gonadotroph adenoma, and PRL-adenoma) with potential sensitivity to somatostatin analogues. - NDduodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma,Gonadotroph adenoma, and PRL-adenoma)MedDRA version: 6.1Level: HLTClassification code 10035098EUCTR2006-002877-30-ITOVARTIS FARMA70
进行中（未招募）
1 期
A phase II, multicentre, open label, prospective, interventional study to evaluate the sperm DNA fragmentation in idiopathic male infertility before and after treatment with Gonal-f PEN 900 IU. - NDIdiophatic male infertilityMedDRA version: 9.1Level: SOCClassification code 10014698EUCTR2010-020196-23-ITMERCK SERONO SPA
进行中（未招募）
不适用
Open label randomized phase II, multicentre, pilot study to evaluate safety and efficacy of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed or not by a complementary treatment with cetuximab in patients with locally advanced oropharynx squamous cell carcinoma.locally advanced oropharynx squamous cell carcinomaEUCTR2005-001816-27-ESClinical Data Care Spain S.L.
进行中（未招募）
2 期
An open label, single centre, phase II pilot study of neoadjuvant dabrafenib + trametinib in patients with resectable AJCC Stage IIIB-C BRAF V600 mutation positive melanomaCancer - Malignant melanomaMelanomaACTRN12613000737730Melanoma Institute Australia35
进行中（未招募）
1 期
An exploratory Phase II, multicenter, open-label trial evaluating the activity and tolerability of of FK228 in androgen independent metastatic prostate cancer patients with a rising PSA. - Depsipeptide in prostate cancerMetastatic prostate cancerMedDRA version: 5.0 Level: CTEP Classification code 10036920EUCTR2005-001576-13-GBGloucester Pharmaceuticals Inc.76