- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01711671
A Study of DKN-01 and Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
A Pilot Study of DKN-01 and Lenalidomide (Revlimid®)/Dexamethasone Versus Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Emory University Hospital
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Relapsed or refractory Multiple Myeloma (MM)
a. Treated with at least 1 prior regimen for myeloma
- Prior treatment with bortezomib (Velcade) is acceptable with a wash-out of 2 weeks
- Treatment with prior autologous transplant is permitted
- If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy
Diagnosis of symptomatic MM as defined by the International Myeloma Working Group (IMWG) :
- Second line or greater/Refractory/Relapsed, Stage I, Stage II, Stage III
- Measureable disease as indicated by monoclonal protein in the serum of greater than or equal to (≥) 1 grams per deciliter (g/dL), involved serum free light chain assay ≥10 mg/dL (≥100 mg/L) provided the serum free light chain ratio is abnormal; monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours, or measurable plasmacytoma
- At least 1 osteolytic bone lesion
- Disease-free of active second/secondary or prior malignancies for equal to or over 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast
- Ambulatory patients greater than or equal to (≥) 30 years of age
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Estimated life expectancy of ≥ 26 weeks
Adequate organ function including:
Hematologic:
- Absolute neutrophil count (ANC) greater than or equal to (≥) 1000/microliter
- Platelet (PLT) count ≥ 75,000/microliter
- Hemoglobin (Hgb) ≥ 8.0 g/dL
Acceptable coagulation status:
- Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)
International normalized ratio (INR) less than or equal to (≤) 1.6 (unless receiving anticoagulation therapy)
- If receiving warfarin: INR ≤ 3.0 (and no active bleeding, [i.e., no bleeding within 14 days prior to first dose of study therapy])
Hepatic:
- Bilirubin ≤ 1.5 x ULN
- Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)
Renal:
- Calculated creatinine clearance ≥ 45 mL using the Cockcroft and Gault Method
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 to 14 days and again within 24 hours of starting study drug
- WCBP must agree to have pregnancy tests monthly (every 14 days for women with irregular cycles) while on study drug and 4 weeks after the last dose of study drug
- Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions starting 4 weeks prior to initiation of the therapy and during the trial and for 18 months following the last dose of study drug
- Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Provide written informed consent prior to any study-specific procedures
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria:
- Received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with DKN-01
- Received any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of entry
- Previously treated with an anti-Dickkopf-1 (anti-DKK-1) or antibody therapy, or have had a significant allergy to a known pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
- Received radiation therapy, surgery, or chemotherapy within 2 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
- Received bisphosphonates (e.g., etidronate, clodronate, tiludronate, pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate) within 2 weeks prior to study entry
- Symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without a history of CNS metastases is not required
- Have a history of major organ transplant (for example: heart, lungs, liver, and kidney)
- Are pregnant or nursing
- Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
- Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection, within 7 days of study entry requiring systemic therapy
- Serious cardiac condition such as myocardial infarction within the past 6 months, unstable angina, or Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); have ECG abnormalities including baseline 12-lead ECG with Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 msec (male), a history of congenital long QT syndrome, or any ECG abnormality that, in the opinion of the Investigator, would preclude safe participation in the study
- History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are considered clinically significant or may have an impact on the interpretation of the scan. Degenerative changes of the hip joint are not exclusionary
- Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this study
- Patients who are currently receiving lithium chloride (LiCl)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: DKN-01 300mg
DKN-01 plus lenalidomide (Revlimid)/dexamethasone
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300 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone
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Экспериментальный: DKN-01 600mg
DKN-01 plus lenalidomide (Revlimid)/dexamethasone
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600 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone
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Активный компаратор: Standard of Care
Lenalidomide (Revlimid)/dexamethasone
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Current approved standard of care
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Fluorine F18 sodium fluoride positron emission tomography (NaF-PET/CT) standard uptake value (SUV)
Временное ограничение: Pre-study to after 6 months of therapy
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SUV as measured by NaF-PET/CT in both myeloma bone lesions and normal bone
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Pre-study to after 6 months of therapy
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Fluorine F18 sodium fluoride positron emission tomography (NaF-PET/CT) influx constant (Ki)
Временное ограничение: Pre-study to after 6 months of therapy
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Ki as measured by NaF-PET/CT in both myeloma bone lesions and normal bone
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Pre-study to after 6 months of therapy
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F18 fluorodeoxyglucose positron emission tomography (FDG-PET/CT) standard uptake value (SUV)
Временное ограничение: Pre-study to after 6 months of therapy
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SUV as measured by FDG-PET/CT in both myeloma bone lesions and normal bone
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Pre-study to after 6 months of therapy
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Number of patients with treatment emergent adverse events
Временное ограничение: Baseline to study completion (approximately 7 months)
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Baseline to study completion (approximately 7 months)
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Overall response rate (ORR)
Временное ограничение: Baseline to study completion (approximately 7 months)
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Baseline to study completion (approximately 7 months)
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Progression free survival (PFS)
Временное ограничение: Baseline to study completion (approximately 7 months)
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Baseline to study completion (approximately 7 months)
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Duration of response
Временное ограничение: Baseline to study completion (approximately 7 months)
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Baseline to study completion (approximately 7 months)
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Overall survival
Временное ограничение: Baseline to study completion (approximately 7 months)
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Baseline to study completion (approximately 7 months)
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Pharmacokinetics: area under the concentration - time curve (AUC) of a single dose of DKN-01
Временное ограничение: Dosing interval of 2 weeks following the first dose in Cycle 1
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Dosing interval of 2 weeks following the first dose in Cycle 1
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Pharmacokinetics: maximum plasma concentration (Cmax) of a single dose of DKN-01
Временное ограничение: Dosing interval of 2 weeks following the first dose in Cycle 1
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Dosing interval of 2 weeks following the first dose in Cycle 1
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Pharmacokinetics: trough DKN-01 concentrations on Cycle 2 and Cycle 3
Временное ограничение: Cycle 2 Day 1 Pre-dose, Cycle 3 Day 1 Pre-dose
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Cycle 2 Day 1 Pre-dose, Cycle 3 Day 1 Pre-dose
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Paul Whitlock, Theorem Clinical Research
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Сердечно-сосудистые заболевания
- Сосудистые заболевания
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Новообразования
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Гематологические заболевания
- Геморрагические расстройства
- Нарушения гемостаза
- Парапротеинемии
- Нарушения белков крови
- Множественная миелома
- Новообразования, Плазматические клетки
- Физиологические эффекты лекарств
- Автономные агенты
- Агенты периферической нервной системы
- Противовоспалительные агенты
- Противоопухолевые агенты
- Иммунологические факторы
- Противорвотные средства
- Желудочно-кишечные агенты
- Глюкокортикоиды
- Гормоны
- Гормоны, заменители гормонов и антагонисты гормонов
- Противоопухолевые агенты, гормональные
- Ингибиторы ангиогенеза
- Агенты, модулирующие ангиогенез
- Вещества роста
- Ингибиторы роста
- Дексаметазон
- Леналидомид
Другие идентификационные номера исследования
- DEK-DKK1-P101
- DKN-01
- LY2812176 (Healthcare Pharmaceuticals)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования DKN-01 300 mg
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Thomas BenfieldРекрутингВИЧ-инфекции | Ожирение | Почечная недостаточность | Остеопороз | ВИЧ | Увеличение веса | ВИЧ липодистрофияДания
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MedImmune LLCЗавершенныйРассеянный склероз, рецидивирующие формыСоединенные Штаты, Испания, Польша, Украина
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University of PadovaНеизвестный
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Johannes Gutenberg University MainzLeap Therapeutics, Inc.Неизвестный
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Maxinovel Pty., Ltd.Еще не набираютРаспространенные/метастатические солидные опухоли
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NHS GrampianЗавершенныйОстеоартрозСоединенное Королевство
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Leap Therapeutics, Inc.Merck Sharp & Dohme LLCЗавершенныйНовообразования пищевода | Аденокарцинома желудка | Аденокарцинома желудочно-пищеводного перехода | Плоскоклеточная карцинома | Гастроэзофагеальный ракСоединенные Штаты
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Stanford UniversityРекрутинг
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ZARS Pharma Inc.Завершенный
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ZARS Pharma Inc.Прекращено