EUCTR2007-003707-12-IT进行中（未招募）不适用
Tandem Autografting-Allografting after Induction Chemotherapy with ?New Drugs? For Newly Diagnosed Myeloma - ND
FONDAZIONE NEOPLASIE SANGUE ONLUS0 个研究点开始时间: 2008年1月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Confirmed diagnosis of symptomatic MM based on standard criteria (including cytogenetic prognostic markers) 2. The patient must have the capacity to give informed consent. 3. Age >18 and < 65 4. Previous enrollment on protocol MM-BO2005 or RV-MM-PI-209 or have received at least 3 courses of induction therapy including either thalidomide, lenalidomide or bortezomib alone or in combination. 5. If female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study 6. If male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study 7. Negative pregnancy test 1. Eta' <18 e >65 anni 2. Karnofsky score inferiore a 60 (vedi appendice C ) , eccetto quello dovuto al Mieloma 3. Frazione di eiezione ventricolare sinistra inferiore al 40%, o coronaropatia sintomatica o altre insufficienze cardiache che richiedono una terapia. 4. Bilirubina 2 volte il limite normale o SCPT e SCROT 4 volte il limite normale. 5. DLCO < 40% (corretta) o necessita' di ricevere ossigenoterapia continua. 6. Pazienti con ipertensione mal controllata. 7. Pazienti con tumori non ematologici attivi (eccetto tumori cutanei diversi dal melanoma). 8. Pazienti con pregressi tumori non-ematologici (eccetto tumori cutanei diversi dal melanoma) in remissione completa da meno di 5 anni o con rischio di recidiva superiore al 20%. 9. Gravidanza. 10. Sieropositivita' al virus del HIV. 11. Uomini o donne fertili che rifiutano di usare metodi contraccettivi durante il trattamento e per i dodici mesi successivi. 12. Clearance Creatinina < 40 cc/min al momento della valutazione dell?autotrapianto
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age <18 and >65 2. Karnofsky score less than 60 (see appendix C), unless due solely to myeloma 3. Left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy 4. Bilirubin greater than 2 X the upper limit of normal, or SGPT and SGOT > 4 X the upper limit of normal 5. DLCO < 40% (corrected) or receiving continuous supplemental oxygen. 6. Patients with poorly controlled hypertension 7. Patients with active non-hematologic malignancies (except non-melanoma skin cancers). 8. Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence 9. Pregnancy 10. Seropositive for the human immunodeficiency virus 11. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment. 12. Creatinine clearance < 40 cc/min at the time of initial autografting evaluation.
研究者
相似试验
进行中（未招募）
不适用
Conditioning with Thiotepa, Busulfan and Fludarabin following allogeneic Transplantation in refractory or relapsed non Hodgkin lymphomas patientsEUCTR2012-005378-73-ITFONDAZIONE NEOPLASIE SANGUE ONLUS
已完成
2 期
Effect of autograft/allograft combination of bone marrow stem cells and Schwann cells on complete chronic and subacute spinal cord injuries.Cronic and subacute spinal cord injuries.Injury of spinal cord, level unspecifiedT09.3IRCT20200502047277N8Shahid Beheshti University of Medical Sciences90
进行中（未招募）
1 期
A randomised controlled trial of regulatory immune cells (Tregs) to allow reduction of immunosuppression following renal transplantation.EUCTR2017-001421-41-GBniversity of Oxford136
进行中（未招募）
1 期
Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple MyelomaEUCTR2007-004928-21-DEniversity Medical Center Hamburg-Eppendorf220
已完成
不适用
Haploidentical transplantation with post-transplant cyclophosphamideJPRN-UMIN000018730Division of Hematology & Oncology, Department of Medicine, Kurume University School of Medicine21