Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients (RAD)
2016年10月14日 更新者:Meletios A. Dimopoulos
Phase II Open Label Study for the Assessment of the Efficacy and Safety of Lenalidomide & Adriamycin & Low Dose Dexamethasone (RAD) in Newly Diagnosed, Symptomatic Multiple Myeloma Patients
This study is to assess the efficacy and safety of lenalidomide in combination with adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
調査の概要
詳細な説明
This is a Phase II, non randomized, non- comparative, open label trial which assess the efficacy and safety of lenalidomide, adriamycin and low dose dexamethasone combination (RAD) in 45 newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
The recruitment period is estimated for 5 months while the treatment period and the follow up period 4 months and 1 month respectively.
During the treatment initiation visit the response to the combination RAD according the International Myeloma Working Group (IMWG) criteria will be evaluated, biochemical markers of bone metabolism and angiogenic cytokines will be measured as well.
IMWG Response evaluation will be repeated the day 1 of each treatment cycle as well as at the response evaluation visit.
Finally biochemical markers of bone metabolism and angiogenic cytokines will be measured once more at the end of treatment visit.
研究の種類
介入
入学 (実際)
45
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Patra、ギリシャ、26504
- University General Hospital of Patras
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Thessaloniki、ギリシャ、54007
- Theageneio Anticancer Hospital of Thessaloniki
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Attica
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Athens、Attica、ギリシャ、11528
- General Hospital of Athens "ALEXANDRA"
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Athens、Attica、ギリシャ、11527
- General Hospital of Athens "G. Gennimatas"
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects able to read and understand the Informed Consent Form (ICF).
- Subjects willing to participate in the study and comply with its procedures.
- Subjects who have signed the ICF
- Newly diagnosed patients with symptomatic MM according to the criteria of IMWG
- Subjects eligible for autologous stem cell transplantation
- Age 18-70 years, of either sex
- karnofsky ≥ 60
- Platelets ≥ 100x109/L
- Neutrophils ≥ 1.5x109/L
- Alanine transaminase (ALT) & Aspartate transaminase (AST) ≤ 3-fold of upper normal limit
- Bilirubin ≤ 2-fold of upper normal limit
- Creatinine clearance ≥60 ml/min
- Expected survival ≥ 6 months as per PI's clinical judgment
- Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation
- Female subject of childbearing potential must have 2 negative serum pregnancy tests (hCG) at Screening (once within 10-14 days and once 24 h before the study drug administration) and if sexually active must be using two medically acceptable, highly effective, adequate forms of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and and for time period at least 28 days before the study drug administration and agree to continue using it while being in the study (Screening and Treatment Periods including dose interruptions). A female subject should continue using a highly effective method of birth control for 30 days following the end of treatment.
- A male subject must agree to use an adequate form of contraception for the duration of the study, while taking the study drug, during dose interruptions at for at least 28 days after the last dose of study drug even if he has had a successful vasectomy and agree to have sexual relations only with women who use a highly effective birth control method.
- Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations
Exclusion Criteria:
- Pregnancy, breastfeeding οr intention of pregnancy during the trial
- Suspected or known hypersensitivity to any of the study drugs
- Ongoing severe infection requiring intravenous antibiotic treatment
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the Prostatic specific antigen (PSA) has been stable for 3 years
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Uncontrolled medical problems such as diabetes, coronary artery disease, hypertension, unstable angina, arrhythmia, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to MM
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study
- Subjects with any clinical condition that would affect study's outcome
- Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study, except of the clinical trials that implicate drugs of supportive treatment
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Lenalidomide, adriamycin & dexamethasone
Lenalidomide 25 mg administered orally for the first 21 days of each 28-day-cycle, plus Adriamycin i.v. on days 1,2,3 & 4 of every cycle, plus Dexamethasone 40 mg orally on days 1, 8, 15 & 22 of every cycle for 4 cycles
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Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles
他の名前:
Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles
他の名前:
Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall response rate
時間枠:142 days
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Assessment of the overall response rate of study population to RAD regimen (including stringent complete response, complete response, very good partial response, partial response and stable disease) according to the uniform criteria of IMWG (International Myeloma Working Group) regarding the response to multiple myeloma therapy
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142 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-free survival (PFS)
時間枠:142 days
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142 days
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Time to progression (TTP)
時間枠:142 days
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142 days
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Time to Next Therapy (TtNT)
時間枠:142 days
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142 days
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Number and severity of Adverse events as a measure of safety and toxicity profile
時間枠:142 days
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Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 2.0)
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142 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT)
時間枠:142 days
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142 days
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Dickkopf-1 (DKK-1)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Dickkopf-1 (DKK-1)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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C-telopeptide of type-I collagen (CTX)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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C-telopeptide of type-I collagen (CTX)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)
時間枠:1 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 days
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Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Bone-alkaline phosphatase (bALP)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Bone-alkaline phosphatase (bALP)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteocalcin (OC)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteocalcin (OC)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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C-terminal propeptide of procollagen type-I (CICP)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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C-terminal propeptide of procollagen type-I (CICP)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Soluble and total RANKL (sRANKL, tRANKL)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Soluble and total RANKL (sRANKL, tRANKL)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteoprotegerin (OPG)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteoprotegerin (OPG)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteopontin (OPN)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteopontin (OPN)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
|
112 days
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Macrophage inflammatory protein 1-alpha (MIP-1α)
時間枠:1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Macrophage inflammatory protein 1-alpha (MIP-1α)
時間枠:112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
|
Angiopoietin-1 & -2
時間枠:1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Angiopoietin-1 & -2
時間枠:112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Angiogenin
時間枠:1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Angiogenin
時間枠:112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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VEGF
時間枠:1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Vascular endothelial growth factor (VEGF)
時間枠:112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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VEGF-A
時間枠:1 day
|
Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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VEGF-A
時間枠:112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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basic fibroblast growth factor (bFGF)
時間枠:1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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basic fibroblast growth factor (bFGF)
時間枠:112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
|
112 days
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Meletios Dimopoulos, Doctor、General Hospital of Athens "ALEXANDRA"
- 主任研究者:Eirini Katodritou, Doctor、Theageneio Anticancer Hospital of Thessaloniki
- 主任研究者:Nikolaos Anagnostopoulos, Doctor、General Hospital of Athens "G. Gennimatas''
- 主任研究者:Argirios Symeonidis, Doctor、University General Hospital of Patras
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年11月1日
一次修了 (実際)
2016年7月1日
研究の完了 (実際)
2016年7月1日
試験登録日
最初に提出
2015年6月5日
QC基準を満たした最初の提出物
2015年6月10日
最初の投稿 (見積もり)
2015年6月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月17日
QC基準を満たした最後の更新が送信されました
2016年10月14日
最終確認日
2016年10月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
- 心血管疾患
- 血管疾患
- 免疫系疾患
- 組織型別の新生物
- 新生物
- リンパ増殖性疾患
- 免疫増殖性疾患
- 血液疾患
- 出血性疾患
- 止血障害
- パラタンパク血症
- 血液タンパク質障害
- 多発性骨髄腫
- 新生物、形質細胞
- 薬の生理作用
- 薬理作用の分子機構
- 自律神経剤
- 末梢神経系エージェント
- 酵素阻害剤
- 抗炎症剤
- 抗悪性腫瘍薬
- 免疫学的要因
- 制吐薬
- 胃腸薬
- グルココルチコイド
- ホルモン
- ホルモン、ホルモン代替物、およびホルモン拮抗薬
- 抗腫瘍剤、ホルモン剤
- プロテアーゼ阻害剤
- トポイソメラーゼ II 阻害剤
- トポイソメラーゼ阻害剤
- 血管新生阻害剤
- 血管新生調節剤
- 成長物質
- 成長阻害剤
- 抗生物質、抗悪性腫瘍薬
- デキサメタゾン
- 酢酸デキサメタゾン
- BB1101
- レナリドミド
- ドキソルビシン
- リポソームドキソルビシン
その他の研究ID番号
- RV-MM-GMSG-392
- 2011-001499-20 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Lenalidomideの臨床試験
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完了