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临床试验/ISRCTN58227268
ISRCTN58227268进行中（未招募）2 期

A randomised phase II trial of cyclophosphamide and dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenolidomide and bortezomib.

niversity of Leeds0 个研究点目标入组 112 人开始时间: 2015年8月26日最近更新:
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适应症

试验速览

阶段
2 期
状态
进行中（未招募）
发起方
入组人数
112
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33008427/ protocol (added 07/10/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35365598/ (added 04/04/2022) 2022 Abstract results in https://doi.org/10.1097/01.hs9.0000829488.58829.9f P11 (added 12/09/2023) 2022 Poster results in https://doi.org/10.1097/01.hs9.0000829616.80742.a1 (added 12/09/2023)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Able to give informed consent and willing to follow study protocol assessments
  • •2. Aged 18 years or over
  • •3. Participants with confirmed MM based on IMWG criteria, 2009
  • •4. Measurable disease with at least one of the following:
  • •4.1. Paraprotein >5g/L or 0.5 g/l for IgD subtype;
  • •4.2. Serum-free light chains >100mg/L with abnormal radio for light chain only myeloma;
  • •4.3. Bence Jones protein >200mg/L
  • •5. Participants with relapsed or relapsed refractory myeloma and now require further treatment following exposure to thalidomide, lenalidomide and bortezomib regardless of response to these
  • •6. ECOG Performance Status = 2
  • •7. Required laboratory values within 14 days prior to Randomisation:
  • •7.1. ­Platelet count =50x109/L. Platelet count of 30­50 is acceptable if bone marrow aspirate shows tumour replacement of >50%. Platelet support is permitted within 14 days prior to randomisation although platelet transfusions to help patients meet eligibility criteria are not allowed within 72 hours prior to the blood sample to confirm protocol eligibility
  • •7.2. ­Absolute neutrophil count =1.0 x 109/L. Growth factor support is not permitted within 14 days prior to randomisation
  • •7.3. Haemoglobin > 9 g/dL. Blood support is permitted
  • •­7.4. ALT and / or AST =3 x upper limit of normal
  • •7.5. ­Creatinine clearance = 30 ml/min (using Cockcroft Gault formula)
  • •7.6. ­Bilirubin =1.5 x upper limit of normal
  • •8. Female participants should avoid becoming pregnant and male participants should avoid impregnating a female partner. Both non­sterilised and sterilised females and males of reproductive age should use effective methods of contraception during the entire trial treatment (including treatment breaks) and up to 90 days after the last dose of trial treatment
  • •9. Post-allograft patients may be included if >12 months from transplant

排除标准

  • •1.Those with non­measurable disease, a solitary bone or solitary extramedullary plasmacytoma, Plasma cell leukaemia
  • •2. Prior malignancy other than those treated with surgery.
  • •3. Participants with a known or underlying uncontrolled concurrent illness that, in the investigators opinion, would make the administration of the study drug hazardous or circumstances that could limit compliance with the study, including, but not limited to the following: acute or chronic graft versus host disease, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within past 6 months, uncontrolled cardiac arrhythmia, renal failure, psychiatric or social conditions that may interfere with participant compliance, or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the participant at unacceptable risk for adverse outcome if he/she were to participate in the study.
  • •4. Patients who have previously received Ixazomib or MLN9708 in a trial. Previous experimental agents or approved anti-tumour treatment within 30 days before the date of randomisation.
  • •5. A maximum of 160mg of dexamethasone (in 40mg blocks) may be given between screening and the beginning of treatment if medically required but should be stopped before trial treatment starts. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted.
  • •6. Participants with a history of a refractory nausea, diarrhoea, vomiting, malabsorption, gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drug(s)
  • •7. Peripheral neuropathy of = grade 2 (or grade 1 with pain) severity (as per NCI­CTCAEv4.0)
  • •8. Gastrointestinal disorders that may interfere with absorption of the study drug
  • •9. Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis
  • •10. Female patients who are lactating or have a positive pregnancy test during the screening period
  • •11. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
  • •12. Systemic treatment, within 14 days before the first dose of Ixazomib, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort
  • •13. Major surgery within 14 days prior to the date of randomisation
  • •14. Radiotherapy within 7 days for palliative pain control or therapeutic radiotherapy within 14 days prior to randomisation
  • •15. Myeloma involving the Central Nervous System

研究者

发起方
niversity of Leeds

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