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Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

14 марта 2019 г. обновлено: Memorial Sloan Kettering Cancer Center

A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

The purpose of this study is to compare the effects, good and bad, of two ways to treat patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma have myeloma with specific features: levels of 2 blood tests have to be in a specific range and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma have done well with intensive therapy in the form of stem cell transplant. But multiple myeloma is not curable and, although it may respond to standard treatments including stem cell transplant, myeloma always recurs.

Обзор исследования

Тип исследования

Интервенционный

Регистрация (Действительный)

67

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

    • New Jersey
      • Basking Ridge, New Jersey, Соединенные Штаты
        • Memoral Sloan Kettering Cancer Center
    • New York
      • Commack, New York, Соединенные Штаты, 11725
        • Memorial Sloan-Kettering Cancer Center @ Suffolk
      • Harrison, New York, Соединенные Штаты, 10604
        • Memorial Sloan Kettering West Harrison
      • New York, New York, Соединенные Штаты, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, Соединенные Штаты
        • Memorial Sloan Kettering at Mercy Medical Center
      • Sleepy Hollow, New York, Соединенные Штаты, 10591
        • Memoral Sloan Kettering Cancer Center at Phelps
      • Sleepy Hollow, New York, Соединенные Штаты, 10591
        • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Age ≥ 18 and ≤ 75
  • Histologic and serologic findings from MSKCC confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the revised International Myeloma Working Group diagnostic criteria.
  • Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma). If immediate therapy with radiation and high-dose steroids (eg, for cord compression) or with bortezomib-based therapy (eg, for renal failure) is required, the patient is not eligible for this trial.
  • Patients may have received 1 cycle of prior therapy with dexamethasone for multiple myeloma.
  • Adequate organ function is required, defined as follows:
  • ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due to multiple myeloma)
  • Serum bilirubin ≤ 2.0 mg/dl
  • AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
  • Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of CrCl (see Appendix I): Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
  • Performance status (ECOG) ≤ 2 (Appendix E).
  • Eligible for SCT with LVEF ≥ 50% by MUGA or ECHO, and diffusing capacity > 50% predicted by pulmonary function testing
  • Ability to understand the investigational nature of this study and to give informed consent
  • All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements the of Revlimid REMS® program
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  • Able to take aspirin 325mg or 81mg daily as prophylactic anticoagulation (patients intolerant to ASA may use Coumadin or low molecular weight heparin).

Exclusion Criteria:

  • Prior treatment for myeloma except for one cycle of dexamethasone
  • History of thromboembolic disease within the past 6 months regardless of anticoagulation
  • Myocardial infarction within 6 months prior to enrollment, or New York Hospital Association (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Pregnant or breast-feeding women are excluded due to the potential teratogenicity of lenalidomide.
  • Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insitu of the cervix, or presence of myelodysplastic or myeloproliferative disease. Patients with prior malignancies with a disease-free interval of ≥ 5 years are eligible.
  • Patients who have had prior malignancies within the past 5 years but are considered to be "cured" with a low likelihood of recurrence may be eligible at the discretion of the Principal Investigator.
  • Active hepatitis B or C infection
  • HIV 1 or 2 positivity
  • Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

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
Экспериментальный: Stem cell transplant x 1 or x 2

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

  • stem cell transplant right after collection
  • continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.

After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.

On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Другие имена:
  • In the initial 4 cycles of therapy, pts will receive oral lenalidomide at the
  • starting dose of 25mg on days 1-21 every 28 days (1 cycle) with dose
  • adjustments for creatinine clearance (CRCL) & dose reductions for toxicity.
  • Pts will receive low-dose oral dexamethasone at 40mg weekly on days 1, 8, 15 &
  • 22 of each 28-day cycle with dose reductions as below for toxicity (the weekly
  • dose could be split over 2 days in the week i.e. 20mg on days 1, 4, 8, 11, 15,
  • 18, 22, & 25 for better tolerance). For SCT, pts are adm to hosp. High-dose
  • melphalan is admin in a single dose on day -2 or split dose on days -3 & -2,
  • through a cvc. Melphalan doseadjustments are made for age & CRCL,. Pts with
  • CRCL,> 51ml/min receive melphalan at 200mg/m2. Pts with CRCL < 51ml/min
  • (to be evaluated within 2 weeks of SCT) will receive 140mg/m2. Pts > 70 years
  • old receive 140mg/m2 also. Each SCT in a tandem SCT is a clinically discrete
  • event & these rules of dose adjustment apply to each SCT. It is possible,
  • that pts will get different doses of melphalan in tandem SCT
Экспериментальный: Continue lenalidomide and dexamethasone

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

stem cell transplant right after collection

  • continue lenalidomide and dexamethasone
  • saving stem cell transplant for a later time.
Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
Другие имена:
  • In the initial 4 cycles of therapy, pts will receive oral lenalidomide at the
  • starting dose of 25mg on days 1-21 every 28 days (one cycle) with dose
  • adjustments for creatinine clearance and dose reductions. Pts will receive
  • low-dose oral dexamethasone at 40mg weekly on days 1, 8, 15 & 22 of each
  • 28-day cycle with dose reductions (the weekly dose could be split over 2 days
  • in the week i.e. 20mg on days 1, 4, 8, 11, 15, 18, 22, & 25 for better
  • tolerance). For continued Ld, pts will resume Ld at the last dose tolerated
  • during the initial 4 cycles, with prophylactics & dose reductions as indicated.
  • Lenalidomide will be continued until progression of disease, if as tolerated.
  • Low-dose dexamethasone will be continued for 1 year (from the start of initial
  • treatment), as tolerated. Dose adjustments will follow guidelines. Pts will
  • be seen every 3 months by their physician & their disease will be reassessed.
  • Pts will also have a CBC & pregnancy test performed monthly.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
Временное ограничение: 2 years
2 years

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Общая выживаемость
Временное ограничение: до 4 лет
до 4 лет
Number of Participants With VGPR + CR Rate
Временное ограничение: 2 years

VGPR/Very Good Partial Response + CR/Complete Response (>/= VGPR) for each study arm

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

2 years
Overall Response Rates
Временное ограничение: 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
2 years

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Hani Hassoun, MD, Memorial Sloan Kettering Cancer Center

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

10 декабря 2008 г.

Первичное завершение (Действительный)

1 июля 2018 г.

Завершение исследования (Действительный)

1 июля 2018 г.

Даты регистрации исследования

Первый отправленный

11 декабря 2008 г.

Впервые представлено, что соответствует критериям контроля качества

11 декабря 2008 г.

Первый опубликованный (Оценивать)

12 декабря 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

15 марта 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 марта 2019 г.

Последняя проверка

1 августа 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 08-121

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 Stem cell transplant x 1 or x 2

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