EUCTR2018-001715-79-IT进行中（未招募）1 期
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-CentreStudy Evaluating the Safety, Tolerability and Efficacy of CombinationTreatment of BL-8040 and G-CSF as compared to Placebo and G-CSF for theMobilization of Hematopoietic Stem Cells for Autologous Transplantation inSubjects with Multiple Myeloma – The GENESIS Study - BL-8040 with G-CSF for Stem Cell Mobilization in multiple myeloma - The GENESIS Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 207
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. Patients must be between the ages of 18 and 78 years.
- •2. Patients must have a signed study informed consent prior to entering
- •3. Histologically confirmed Multiple Myeloma prior to enrollment and
- •randomization.
- •4. At least 4 weeks (28 days) from last induction cycle of
- •combination/multi-agent chemotherapy (e.g. KRD [carfilzomib,
- •lenalidomide, dexamethasone] or VRD [bortezomib, lenalidomide,
- •dexamethasone]) and at least 7 days from last single agent
- •chemotherapy (e.g. lenalidomide, pomalidomide, bortezomib,
- •dexamethasone, etc) prior to the first dose of G-CSF for mobilization.
- •5. Eligible for Autologous Hematopoietic stem cell transplantation
- •according to the investigator's discretion.
- •6. The subjects should be in first or second CR (including CR and SCR) or
- •PR (including PR and VGPR).
- •7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •8. Adequate organ function at baseline as defined below:
- •a. Hematology:
- •White blood cell count more than 2.5 x 10^9/L,
- •Absolute neutrophil count more than 1.5 x 10^9/L
- •Platelet count more than 100 x10^9/L
- •b. Renal Function:
- •Serum creatinine =2.2 mg/dL or creatinine clearance (CrCl) value of =
- •50 ml/min by MDRD equation, whichever is more stringent.
- •c. Hepatic function:
- •ALT and/or AST = 2.5 x ULN
- •Total Bilirubin = 2.0 x ULN unless the subject has Gilbert disease
- •d. Coagulation test:
- •INR or PT: =1.5xULN unless subject is receiving anticoagulant therapy,
- •as long as PT or PTT is within therapeutic range of intended use of
- •anticoagulants
- •aPTT: =1.5xULN unless subject is receiving anticoagulant therapy as
- •long as PT or PTT is within therapeutic range of intended use of
- •anticoagulants
- •9. Subjects must use effective contraception:
- •e. Female subjects must be of non-childbearing potential or, if of
- •childbearing potential, must have a negative urine or serum pregnancy
- •test within 72 hours prior to taking study medication. If the urine test is
- •positive or cannot be confirmed as negative, a serum pregnancy test will
- •be required. The serum pregnancy test must be negative for the subject
- •to be eligible. Non-childbearing potential is defined as (by other than
- •medical reasons):
- •=45 years of age and has not had menses for over 2 years.
- •Amenorrheic for > 2 years without a hysterectomy and oophorectomy
- •and a Follicle Stimulating Hormone (FSH) value in the postmenopausal
- •range upon pre-trial (screening) evaluation.
- •Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or
- •bilateral tubal ligation at least 6 weeks prior to screening. Documented
- •hysterectomy or oophorectomy must be confirmed with medical records
- •of the actual procedure or confirmed by ultrasound. Tubal ligation must
- •be confirmed with medical records of the actual procedure otherwise the
- 另有 13 项未显示
排除标准
- •1. Previous history of autologous or allogeneic-HCT.
- •2. Failed previous HSC collections or collection attempts.
- •3. Patients whose apheresis product will have to be further selected and
- •4. Taken any of the listed below concomitant medications, growth
- •factors or stimulating agents within the designated washout period:
- •a. Dexamethasone: 7 days
- •b. Thalidomide: 7 days
- •c. Lenalidomide: 7 days
- •d. Pamolidomide: 7 days
- •e. Bortezomib: 7 days
- •f. Carfilzomib: 7 days
- •g. G-CSF: 14 days
- •h. GM-CSF or Neulasta®: 21 days
- •i. Combination/multi-agent cyto-reductive therapy: 28 days
- •j. Erythropoietin or erythrocyte stimulating agents: 30 days
- •k. Eltrombopag, romiplostim or platelet stimulating agents: 30 days
- •l. Carmustine (BCNU): 42 days/6 weeks
- •5. Received >6 cycles lifetime exposure to Lenalidomide.
- •6. Received >8 cycles of alkylating agent combinations
- •7. Received > 6 cycles of melphalan.
- •8. Received prior treatment with radioimmunotherapy, (e.g.
- •radionuclides, holmium).
- •9. Plans to receive maintenance treatment within 100 days postengraftment
- •(e.g. Lenalidomide, Bortezomib, Pomalidomide,
- •Thalidomide, Carfilzomib, etc.).
- •10. Has received a live vaccine within 30 days of the planned start of
- •study therapy. Seasonal flu vaccines that do not contain live virus are
- •11. Known active CNS metastases or carcinomatous meningitis.
- •12. A history of allergic reactions attributed to compounds of similar
- •chemical or biologic composition to BL-8040, G-CSF, or other agents
- •used in the study.
- •13. Has an active or uncontrolled infection requiring systemic therapy.
- •14. Has a known additional malignancy that is progressing or requires
- •active treatment.
- •15. Has an underlying medical condition that would preclude study
- •participation.
- •16. Is currently participating and receiving study therapy or has
- •participated in a study of an investigational agent and received study
- •therapy or used an investigational device within 4 weeks of the first
- •dose of treatment.
- •17. O2 saturation < 92% (on room air).
- •18. Personal history or family history of Long QT Syndrome or Torsade
- •19. History of unexplained syncope, syncope from an uncorrected
- •cardiac etiology, or family history of sudden cardiac death.
- •20. Myocardial infarction, CABG, coronary or cerebral artery stenting and
- •/or angioplasty, stroke, cardiac surgery, or hospitalization for congestive
- •heart failure within 3 months, Angina Pectoris Class >2 or NYHA Heart
- •Failure Class >2.
- •21. ECG at screening or baseline showing QTcF > 470 msec and/or PR >
- •22. Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or
- 另有 14 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856EUCTR2018-003985-15-PTArena Pharmaceuticals Inc.433
进行中（未招募）
1 期
A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisEUCTR2019-000968-18-CZCB Biopharma SR240
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyHomologous recombination deficiency advanced ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000952-11-ITTESARO, INCORPORATED733
进行中（未招募）
1 期
A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)EUCTR2016-004148-13-PTGilead Sciences, Inc.800
招募中
1 期
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung Cancerung Cancer, Non-Small CellMedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-508443-40-00Glaxosmithkline Research & Development Limited644