Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
2016年10月18日 更新者：Paul G. Richardson, MD、Dana-Farber Cancer Institute
Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma.
Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
調査の概要
詳細な説明
- Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
- Certain tests and procedures were performed throughout each treatment cycle at definitive time periods. These tests included: medical history update, physical/neurological examination, skeletal survey (x-rays or scan), blood samples, urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT (if needed).
- It was expected that participants were going to complete at least 8 cycles of the study, which adds up to 168 days. If the participant completed the first 8 cycles, had stable or responding disease and had not experienced bad side effects, they were allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
研究の種類
介入
入学 (実際)
65
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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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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年歳以上 (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:
- Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
- Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens
- Negative serum or urine pregnancy test
- Age 18 years or older
- Karnofsky performance status of 60 or greater
Exclusion Criteria:
- Grade 2 or greater peripheral neuropathy within 14 days before enrollment
- Renal insufficiency (serum creatinine > 2.5 mg/dL)
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC < 1000 cells/mm3
- Hemoglobin < 8.0 g/dL
- AST or ALT greater than or equal to 2 x ULN
- Concomitant therapy medications that include corticosteroids
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Clinically relevant active infection or serious co-morbid medical conditions
- Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
- Pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes mellitus
- Hypersensitivity to acyclovir or similar anti-viral drug
- POEMS syndrome
- Known HIV infection
- Known active hepatitis B or C viral infection
- Known intolerance to steroid therapy
- Subjects with primary refractory disease, defined as progression during initial 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 |
|---|---|
|
実験的：lenalidomide, dexamethasone, bortezomib combination
Participants took the study medication in the clinic on Cycle 1 day 1.
Each treatment cycle lasted three weeks.
They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14).
They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11.
The third week of the cycle was a rest period and the participant did not take any study medication.
|
Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
|
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 |
|---|---|---|
|
The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
時間枠：6 months after therapy
|
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: >25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). |
6 months after therapy
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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 |
|---|---|---|
|
Objective Response Rate
時間枠：Assessed every cycle for up to 8 cycles and best response was reported
|
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response). |
Assessed every cycle for up to 8 cycles and best response was reported
|
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Duration of Response
時間枠：Assessed at a median follow-up of 44 months
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Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.
|
Assessed at a median follow-up of 44 months
|
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Progression Free Survival
時間枠：aassesed at a median follow-up of 44 months
|
Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.
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aassesed at a median follow-up of 44 months
|
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Overall Survival
時間枠：assesed at a median follow-up of 44 months
|
defined as time from treatment initiation to death, or last known to be alive for those who had not died
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assesed at a median follow-up of 44 months
|
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8月1日
一次修了 (実際)
2012年10月1日
研究の完了 (実際)
2016年10月1日
試験登録日
最初に提出
2006年9月18日
QC基準を満たした最初の提出物
2006年9月18日
最初の投稿 (見積もり)
2006年9月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11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18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
その他の研究ID番号
- 06-147
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