- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02206503
Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM)
A PHASE II, MULTI-CENTER, OPEN LABEL STUDY OF CYCLOPHOSPHAMIDE IN MULTIPLE MYELOMA PATIENTS WITH BIOCHEMICAL PROGRESSION DURING LENALIDOMIDE-DEXAMETHASONE TREATMENT FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA
연구 개요
상세 설명
This protocol is a phase II multicenter, open label study designed to determine whether the addiction of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
The pre-treatment period includes: screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above. Subjects who meet all the inclusion criteria will be enrolled.
The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle.
During the LTFU period, after development of confirmed progression disease (PD), all patients are to be followed for survival every 1-3 months via telephone or office visit.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Rome, 이탈리아, 00161
- Policlinico Umberto I
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient with relapse/refractory multiple myeloma who experienced biochemical progression, without CRAB, during treatment with Rd. CRAB means the presence of organ damage, multiple myeloma related (renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia). It is sufficient one of the previous signs for defining the presence of CRAB. Biochemical progression means: positivization of serum/urine immunofixation for patients who reached a complete remission with Rd treatment or at least 25% increment of monoclonal component in serum/urine for patients who reached at least a stable disease (SD).
- Patient exposed to previous therapy included Lenalidomide, Thalidomide, Bortezomib and/or autologous stem cell transplantation (ASCT) and in treatment with Rd.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal or surgically sterilized or, if at childbearing potential, must: understand that the study medication could have an expected teratogenic risk.
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*:
- Implant**
- Levonorgestrel-releasing intrauterine system (IUS)**
- Medroxyprogesterone acetate depot
- Tubal sterilisation
- Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
- Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.
- **prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection.
- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mills International Units on milliliter (mIU/ml) not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
† A female subject or a female partner of a male subject is considered to have childbearing potential unless she meets at least one of the following criteria: Age
≥50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential), premature ovarian failure confirmed by a specialist gynaecologist, previous bilateral salpingooophorectomy or hysterectomy, xy genotype, Turner's syndrome or uterine agenesis.
Male subjects must:
- Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
All subjects must:
- Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused study drug to the investigator.
- Patient who obtain at least a SD with Rd treatment and experienced a biochemical progression without CRAB, during the treatment itself.
- Patient has a Karnofsky performance status ≥ 60%.
- Patient has a life-expectancy > 6 months.
- Patients must have a adequate cardiac function.
- Patients must have adequate pulmonary function.
Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cyclophosphamide):
- Platelet count ≥ 50 x 109/L or ≥ 25 109/L if bone marrow involvement is ≥ 50% of plasma cells in bone marrow biopsy.
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L or ≥ 0,5 109/L x if bone marrow involvement is ≥ 50% of plasma cells in bone marrow biopsy.
- Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L).
- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
- Alanine transaminase (ALT): ≤ 2.5 x the ULN.
- Total bilirubin: ≤ 1.5 x the ULN.
- Calculated or measured creatinine clearance: ≥ 30 mL/minute.
Exclusion Criteria:
- Patients with newly diagnosed multiple myeloma.
- Patients who relapsed from multiple myeloma with signs of organ damage related to disease (CRAB).
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females.
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cyclophosphamide; Lenalidomide; Dexamethasone
MM Patients who experienced biochemical progression during Rd treatment without CRAB (signs of organ damage, multiple myeloma-related, as renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia), will continue:
Adding: · Cyclophosphamide orally at the dose of 50 mg/day on days 1-21 every 28 days. CRd combination will be continued for 9-4week cycles. Patients will not receive any maintenance therapy. |
This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment.
The treatment period includes: administration of the combination CRd for 9 cycles.
In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks.
The response will be assessed after each cycle.
During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Efficacy in terms of response and survival
기간: 2 years
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To assess the efficacy (response rate according to International Myeloma Working Group (IMWG) definition, appendix 2) after the addiction of Cyclophosphamide to Revlimid-Dexamethasone (CRd) in Multiple Myeloma patients, who experienced a biochemical progression during Rd treatment, without myeloma-related organ damage, CRAB.
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time to next therapy (TNT)
기간: 2 years
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2 years
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Safety in terms of hematological and non-hematological adverse events
기간: 2 years
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The following evaluations will be conducted to assess the safety:
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2 years
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The progression free survival (PFS)
기간: 2 years
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2 years
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The overall survival (OS)
기간: 2 years
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2 years
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Duration of time to progression (TTP)
기간: 2 years
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2 years
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Identification of patient's subgroups according to specific prognostic factors
기간: 2 years
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Teresa Petrucci, MD, Policlinico Umberto I
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 병리학적 과정
- 심혈관 질환
- 혈관 질환
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 림프 증식 장애
- 면역증식성 장애
- 질병 속성
- 혈액 질환
- 출혈성 장애
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 질병 진행
- 다발성 골수종
- 신생물, 형질세포
- 약물의 생리적 효과
- 약리작용의 분자기전
- 자율 작용제
- 말초 신경계 작용제
- 항염증제
- 항류마티스제
- 항종양제
- 면역억제제
- 면역학적 요인
- 항구토제
- 위장약
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 항종양제, 알킬화제
- 알킬화제
- 골수 파괴 작용제
- 혈관신생 억제제
- 혈관신생 조절제
- 성장 물질
- 성장 억제제
- 덱사메타손
- 사이클로포스파마이드
- 레날리도마이드
기타 연구 ID 번호
- CRd
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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