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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

2019년 3월 14일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (실제)

67

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

다른 이름들:
  • 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
실험적: 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.
다른 이름들:
  • 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
기간: 2 years
2 years

2차 결과 측정

결과 측정
측정값 설명
기간
전반적인 생존
기간: 최대 4년
최대 4년
Number of Participants With VGPR + CR Rate
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Hani Hassoun, MD, Memorial Sloan Kettering Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 12월 10일

기본 완료 (실제)

2018년 7월 1일

연구 완료 (실제)

2018년 7월 1일

연구 등록 날짜

최초 제출

2008년 12월 11일

QC 기준을 충족하는 최초 제출

2008년 12월 11일

처음 게시됨 (추정)

2008년 12월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 14일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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