An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade
2014年6月10日 更新者：Xian-Janssen Pharmaceutical Ltd.
Velcade (Bortezomib for Injection) Observational Study
The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.
調査の概要
詳細な説明
This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade.
The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase.
In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors.
Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade.
In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period.
Each treatment cycle consists of 21 days.
Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade.
In the follow up phase, patients will be followed for up to three years to document long-term survival data.
For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process.
Safety evaluations will be based on the incidence, intensity, and types of adverse events.
The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.
研究の種類
観察的
入学 (実際)
532
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年歳未満 (子、大人)
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
サンプリング方法
非確率サンプル
調査対象母集団
Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating Velcade therapy within the approved indication.
説明
Inclusion Criteria:
- Must give informed consent in agreement with local legislation
- Must not have any contraindication listed in package insert
Exclusion Criteria:
- Patients currently participating in another investigational study of Velcade or any other medication
- Patients with severe hepatic or renal impairment
- Patients with platelet count below 25000/μl
- Patients who are considered disqualified for the study by the investigators
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Velcade
Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
|
This is an observational study.
Velcade will be administered as per the recommended regimen.
(Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)
|
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 |
|---|---|---|
|
Information on treatment sequence for Velcade therapy
時間枠：Baseline (Day -1) to Day 21
|
Treatment sequence or the line of therapy will be considered on Velcade utilization.
|
Baseline (Day -1) to Day 21
|
|
Information on dosage of Velcade
時間枠：Baseline to Day 21
|
Dosage of Velcade will be considered on Velcade utilization.
The unit of dosage will be milligram per square meter body surface area.
|
Baseline to Day 21
|
|
Information on duration of Velcade therapy
時間枠：Baseline to Day 21
|
Duration of Velcade therapy will be measured on Velcade utilization.
The unit of duration will be number of days or the length of the course of therapy.
|
Baseline to Day 21
|
|
Information on patient diagnosis for Velcade therapy
時間枠：Baseline to Day 21
|
Diagnosis of patients will be considered on Velcade utilization.
|
Baseline to Day 21
|
|
Number of patients with disease response or progression
時間枠：Up to 3 years
|
Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.
|
Up to 3 years
|
|
Time to response
時間枠：Up to 3 years
|
Time to response is calculated from the start date of the cycle of Velcade therapy.
|
Up to 3 years
|
|
Duration of response
時間枠：Up to 3 years
|
Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.
|
Up to 3 years
|
|
Time to progression
時間枠：Up to 3 years
|
Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
|
Up to 3 years
|
|
Survival status
時間枠：Up to 3 years
|
Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.
|
Up to 3 years
|
|
Number of patients with adverse events
時間枠：Up to 3 years
|
Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria [WHO CTC]), and any neurotoxic events by WHO CTC.
|
Up to 3 years
|
|
Number of emergency room visits while using Velcade therapy
時間枠：Up to 3 years
|
Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of inpatient hospital stays while using Velcade therapy
時間枠：Up to 3 years
|
Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of days for each hospital stay
時間枠：Up to 3 years
|
Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of patients on whom therapeutic therapies will be conducted
時間枠：Up to 3 years
|
Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.
|
Up to 3 years
|
|
Number of patients on whom chest radiograph will be conducted
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom whole-body bone scan will be conducted
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on whom radiograph for designated area will be conducted
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Serum immunoglobin and M-protein
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
M-protein detected by immunofixation electrophoresis
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Urine light chain M-protein
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Bone marrow puncture and biopsy
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
β2-microglobulin
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
C-reactive protein
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Lactate dehydrogenase
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Routine blood examination
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Liver function test
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Renal function test
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Serum electrolytes
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Number of patients on concomitant medications
時間枠：Up to 3 years
|
Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy.
Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication.
The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.
|
Up to 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Indications for Velcade therapy
時間枠：Baseline (Day -1)
|
Multiple myeloma patients who receive two or more prior treatments and demonstrate disease progression on the most recent treatment will be indicated for Velcade therapy.
|
Baseline (Day -1)
|
|
Sociodemographics for Velcade therapy
時間枠：Baseline
|
Sociodemographics of patients will be assessed, at the initiation of Velcade therapy, such as: gender, date of birth, height, weight, highest degree, and career information.
|
Baseline
|
|
Number of chronic concomitant disease
時間枠：Baseline
|
Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
|
Baseline
|
|
Treatment history
時間枠：Baseline
|
Treatment history will be assessed at the initiation of Velcade therapy.
Treatment history includes: confirmation date of diagnosis of multiple myeloma patients or other patients receiving Velcade therapy; names of diseases for patient receiving Velcade therapy; prior treatments for multiple myeloma; outcomes of prior treatments for multiple myeloma.
|
Baseline
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2006年3月1日
一次修了 (実際)
2010年5月1日
研究の完了 (実際)
2010年5月1日
試験登録日
最初に提出
2012年8月27日
QC基準を満たした最初の提出物
2012年8月27日
最初の投稿 (見積もり)
2012年8月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年6月11日
QC基準を満たした最後の更新が送信されました
2014年6月10日
最終確認日
2014年6月1日
詳しくは
本研究に関する用語
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