ISRCTN25958282进行中（未招募）1 期
89Zr-belantamab PET-CT imaging to detect myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
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
- •1. Any individual with a confirmed case of multiple myeloma or multifocal plasmacytoma with lesions demonstrable on imaging performed within 4 weeks of start of trial.
- •2. At least one skeletal myeloma deposit >0.5 cm in diameter.
- •3. Patients who are able to tolerate the study protocol.
- •4. Participant is willing and able to give informed consent for participation in the trial.
- •5. Participants must be aged 30 years or above.
- •6. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •8. Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met:
- •8.1. ASCT was >100 days prior to initiating study treatment, and
- •8.2. No active bacterial, viral, or fungal infection(s) present.
- •9. All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0) must be = Grade 1 at the time of enrollment, except for alopecia.
- •10. Participant has clinically acceptable laboratory results within 4 weeks of enrolment
- •11. A female participant is eligible to participate if she is of non-childbearing potential, defined as one of the following:
- •11.1. = 45 years of age and has not had menses for > 2 years
- •11.2. Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.
- •11.3. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 24 months of amenorrhea, confirmation with more than one FSH measurement is required. In questionable cases a blood sample with simultaneous FSH >40 MIU/mL and estradiol.
- •11.4. Females on HRT and whose menopausal status is in doubt will be required to use one of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrolment.
- •11.5. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
- •12. Male participants are eligible to participate if they agree to the following from the time of first dose of study until 6 months after the last dose of belantamab to allow for clearance of any altered sperm:
- •12.1. Refrain from donating sperm
- •PLUS either:
- •12.2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- •12.3. Must agree to use contraception/barrier:
- •12.3.1. Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as described in section 11.2 when having sexual intercourse with a woman of childbearing potential (including pregnant females).
- •12.3.2. Contraceptive use should be consistent with local
排除标准
- •1. The presence of only extramedullary lesions as determined by imaging performed within 4 weeks of start of trial.
- •2. Significant renal (infection, requirement for dialysis or any other condition that could affect participant’s safety) or hepatic (current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: 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) impairment.
- •3. Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria
- •4. Participant with life expectancy of less than 6 months.
- •5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- •6. Participants who have participated in another research trial involving an unlicensed product in the past 12 weeks.
- •7. Participants that have undertaken more than two rounds of chemotherapy.
- •8. Patients who would not be able to tolerate lying supine, within the gantry of a PET-CT scanner, with a total duration of up to 1 hour.
- •9. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
- •10. Participant currently has corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
- •11. Patients with ongoing or recent BCMA targeted myeloma treatment which can be expected to affect lesion BCMA expression.
- •12. Participant must not have used an investigational anti-myeloma drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
- •13. Participant must not have evidence of cardiovascular risk including any of the following:
- •13.1. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
- •13.2. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.
- •13.3. QTcF interval >450 msec (QT interval corrected for heart rate according to Fridericia’s formula), and/or hypokalemia, and/or family history of long QT syndrome.
- •13.4. Class III or IV heart failure as defined by the New York Heart Association functional classification system, [NYHA, 1994]
- •13.5. Uncontrolled hypertension
- •14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab or any of the components of the study treatment. History of severe hypersensitivity to other mAbs.
- •15. Smouldering MM, Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukaemia at the time of screening.
- •16. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance to the
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