ISRCTN19869915进行中（未招募）1 期
A platform trial for relapsed patients to evaluate ongoing novel therapies in multiple myeloma in combination with standard of care therapies
niversity of Leeds0 个研究点目标入组 40 人开始时间: 2021年1月7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
- 40
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 07/11/2023:
- •1. Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG) criteria
- •2. Relapsed or refractory disease, having received between 1 and 3 prior lines of therapy which include a proteasome inhibitor (including bortezomib, carfilzomib, ixazomib) and an immunomodulatory imide drug (including thalidomide, lenalidomide, pomalidomide).
- •3. Have measurable disease with at least one of the following:
- •3.1. Paraprotein =5 g/l
- •3.2. Serum free light chains =100 mg/l with abnormal ratio for light chain only myeloma
- •3.3. Bence Jones protein = 200 mg/day
- •4. Aged =18 years on day of signing informed consent
- •5. Not pregnant or breastfeeding, and one of the following conditions applies:
- •5.1. Not a woman of childbearing potential (WOCBP)
- •5.2. Is a WOCBP and all of the following apply:
- •5.2.1. Is using a highly effective (with a failure rate of <1% per year) method of contraception (preferably with low user dependency) from 4 weeks prior to the start of treatment, during the intervention period, and for the contraceptive time frame specified in the arm specific eligibility criteria.
- •5.2.2. Have a negative urine or serum pregnancy test as outlined in each treatment sub-protocol and agree to use a highly effective method of contraception from 4 weeks prior to the start of treatment, during the study, and for 9 months after the last dose of belamaf
- •5.2.3. Have agreed not to donate eggs (ova, oocytes) for the purpose of reproduction during this period
- •6. Male participants of childbearing potential who agree to one of the following from the time of dosing on C1D1 until 6 months after the last dose of study treatment, to allow for clearance of any altered sperm:
- •6.1. Abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), or agree to use a male condom (even if they have undergone a successful vasectomy)
- •6.2. If applicable, WOCBP (including pregnant females) partners to use an additional highly effective contraceptive method with a failure rate of <1% per year
- •6.3 Refrain from donating sperm during this period
- •7. Agree to refrain from donating blood while on trial drug, including during dose interruptions and for 120 days after discontinuation from this trial
- •8. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03), except for alopecia, must be =Grade 1 at the time of enrolment
- •9. Adequate organ function as defined by the following assessments:
- •9.1. Absolute neutrophil count (ANC) =1 X 109/L
- •9.2. Haemoglobin =80 g/l
- •9.3. Platelets =75 x10?/l
- •9.4. Total bilirubin =1.5 x ULN
- •9.5. ALT =2.5 x ULN
- •10. Calculated creatinine clearance =40 ml/min/1.73 m² using Cockcroft-Gault formula
- •11. Spot urine <500 mg/g
- •Previous inclusion criteria:
- •1. Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG) criteria
- •2. Relapsed or refractory disease, having received between 1 and 3 prior lines of therapy which include a proteasome inhibitor (including bortezomib, carfilzomib, ixazomib) and an immunomodulatory imide drug (including thalidomide, lenalidomide, pomalidomide).
- •3. Have measurable disease with at least one of the following:
- •3.1. Paraprotein =5 g/l
- •3.2. Serum free light chains =100
排除标准
- •Current exclusion criteria as of 07/11/2023:
- •1. Non-measurable disease, solitary bone or solitary extramedullary plasmacytoma, plasma cell leukaemia, POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or systemic amyloidosis
- •2. Currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 28 days prior to dose allocation
- •3. Any of the following prior treatments:
- •3.1. Autologous stem cell transplantation <3 months prior to dose allocation
- •3.2. Anti-cancer monoclonal antibody (mAb) within 14 days prior to dose allocation or who has not recovered (=Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier =Grade 2 neuropathy with no pain is an exception to this criterion.
- •3.3. Chemotherapy, targeted small molecule therapy, or therapeutic radiation therapy within 14 days prior to dose allocation or who has not recovered (=Grade 1 or at baseline) from adverse events due to a previously administered agent. =Grade 2 neuropathy with no pain is an exception to this criterion. Palliative radiotherapy for pain control and bisphosphonates is permitted
- •3.4. Treatment with plasmapheresis within 4 weeks prior to dose allocation (Palliative radiotherapy for pain control and bisphosphonates is permitted. Corticosteroids for myeloma disease control are permitted up to 7 days prior to 1st dose.)
- •4. Significant cardiac disease as determined by the investigator including:
- •4.1. Known or suspected cardiac amyloidosis
- •4.2. Congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification
- •4.3. Uncontrolled angina, hypertension, or arrhythmia
- •4.4. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting in the past 3 months prior to dose allocation
- •4.5. Uncontrolled or severe cardiovascular disease including uncontrolled hypertension, clinically significant uncontrolled and/or untreated arrhythmias, ECG abnormalities such as second degree (Mobitz Type II) or 3rd degree atrioventricular block Corrected QT interval (QTcF) >530 msec based on average value of triplicate ECGs performed within 14 days of registration
- •5. Prior treatment with a B-cell maturation antigen (BCMA) targeted therapy
- •6. Current corneal epithelial disease except for mild changes in corneal epithelium
- •7. Requirement to wear contact lenses
- •8. Active renal condition (infection, requirement for dialysis, or any other condition that could affect participant’s safety) or unstable liver or biliary disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis) per investigator assessment. Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) or hepatobiliary involvement of
- •malignancy is acceptable if otherwise meets entry criteria.
- •9. Known history of Human Immunodeficiency Virus (HIV)
- •10. Known active Hepatitis B or Hepatitis C confirmed by antibody test or RNA test within 3 months prior to dose allocation.
- •11. Any major surgery within 4 weeks prior to dose allocation.
- •12. Active infection requiring systemic antibiotic, antiviral, or antifungal treatment within 7 days of dose allocation.
- •13. Known immediate or dela
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