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S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

2015년 3월 5일 업데이트: Southwest Oncology Group

Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma

RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

  • Compare the progression-free survival of patients with previously untreated stage I, II, or III multiple myeloma treated with dexamethasone with or without lenalidomide.
  • Compare the overall response rate in patients treated with these regimens.
  • Compare the major response rate (indicated by greater than 75% decrease in M-protein) in patients treated with these regimens.
  • Compare the overall survival and time to best response in patients treated with these regimens.
  • Compare the toxicity profile of these regimens, including thrombotic complications, in these patients.
  • Compare the effect of these regimens on gene expression and proteomic analysis in these patients.

OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are stratified according to disease stage by the International Staging System (I vs II vs III) and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

Arm I

  • Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm II

  • Induction therapy: Patients receive DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction.

Patients with responding or stable disease proceed to maintenance therapy. Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.

  • Maintenance therapy: Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.

Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.

Patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.

연구 유형

중재적

등록 (실제)

198

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 미국
    • Michigan
      • Royal Oak, Michigan, 미국, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Utah
      • Salt Lake City, Utah, 미국, 84106
        • Utah Cancer Specialists at UCS Cancer 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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

DISEASE CHARACTERISTICS:

  • Previously untreated multiple myeloma

    • Stage I, II, or III disease by the International Staging System

  • Measurable M-protein as defined by 1 of the following:

    • Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis
    • Urinary M-protein excretion at least 200 mg/24 hours
  • No nonsecretory multiple myeloma
  • Not planning to undergo future autologous stem cell transplantation

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of disability

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 80,000/mm^3*
  • Absolute neutrophil count at least 1,000/mm^3*
  • Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to greater than 50% marrow involvement by myeloma on biopsy

Hepatic

  • AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this range are allowed at the investigator's discretion

Renal

  • Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed at the investigator's discretion

Cardiovascular

  • No New York Heart Association class III or IV heart failure
  • No myocardial infarction within the past 6 months
  • No poorly controlled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test

  • Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment

    • Female patients must use 2 reliable forms of contraception simultaneously
    • Male patients must use effective barrier contraception
  • No uncontrolled active infection requiring IV antibiotics
  • No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids
  • No other serious medical condition that would preclude study participation
  • No psychiatric illness that would preclude study participation
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except if already on therapeutic anticoagulant medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interferon or thalidomide

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days

Radiotherapy

  • Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease

Surgery

  • Not specified

Other

  • No prior treatment for clinically significant ventricular cardiac arrhythmias
  • Concurrent bisphosphonates allowed

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm I
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
의약품: 덱사메타손
구두로 주어진
의약품: 레날리도마이드
구두로 주어진
활성 비교기: Arm II
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
의약품: 덱사메타손
구두로 주어진
다른: 위약
구두로 주어진

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival
기간: From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years

Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.

In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.
From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Toxicity
기간: From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years
Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.
From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Southwest Oncology Group

협력자

National Cancer Institute (NCI)

간행물 및 유용한 링크

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

일반 간행물

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

2004년 11월 1일

기본 완료 (실제)

2008년 10월 1일

연구 완료 (실제)

2012년 5월 1일

연구 등록 날짜

최초 제출

2003년 7월 8일

QC 기준을 충족하는 최초 제출

2003년 7월 8일

처음 게시됨 (추정)

2003년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 3월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 3월 5일

마지막으로 확인됨

2015년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • S0232 (기타 식별자: SWOG)
  • U10CA032102 (미국 NIH 보조금/계약)

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. .

다발성 골수종에 대한 임상 시험

덱사메타손에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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