Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L
A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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New Jersey
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Basking Ridge、New Jersey、アメリカ
- Memoral Sloan Kettering Cancer Center
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New York
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Commack、New York、アメリカ、11725
- Memorial Sloan-Kettering Cancer Center @ Suffolk
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Harrison、New York、アメリカ、10604
- Memorial Sloan Kettering West Harrison
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre、New York、アメリカ
- Memorial Sloan Kettering at Mercy Medical Center
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Sleepy Hollow、New York、アメリカ、10591
- Memoral Sloan Kettering Cancer Center at Phelps
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Sleepy Hollow、New York、アメリカ、10591
- Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 18 and ≤ 75
- Histologic and serologic findings from MSKCC confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the revised International Myeloma Working Group diagnostic criteria.
- Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma). If immediate therapy with radiation and high-dose steroids (eg, for cord compression) or with bortezomib-based therapy (eg, for renal failure) is required, the patient is not eligible for this trial.
- Patients may have received 1 cycle of prior therapy with dexamethasone for multiple myeloma.
- Adequate organ function is required, defined as follows:
- ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due to multiple myeloma)
- Serum bilirubin ≤ 2.0 mg/dl
- AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
- Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of CrCl (see Appendix I): Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
- Performance status (ECOG) ≤ 2 (Appendix E).
- Eligible for SCT with LVEF ≥ 50% by MUGA or ECHO, and diffusing capacity > 50% predicted by pulmonary function testing
- Ability to understand the investigational nature of this study and to give informed consent
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements the of Revlimid REMS® program
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin 325mg or 81mg daily as prophylactic anticoagulation (patients intolerant to ASA may use Coumadin or low molecular weight heparin).
Exclusion Criteria:
- Prior treatment for myeloma except for one cycle of dexamethasone
- History of thromboembolic disease within the past 6 months regardless of anticoagulation
- Myocardial infarction within 6 months prior to enrollment, or New York Hospital Association (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Pregnant or breast-feeding women are excluded due to the potential teratogenicity of lenalidomide.
- Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insitu of the cervix, or presence of myelodysplastic or myeloproliferative disease. Patients with prior malignancies with a disease-free interval of ≥ 5 years are eligible.
- Patients who have had prior malignancies within the past 5 years but are considered to be "cured" with a low likelihood of recurrence may be eligible at the discretion of the Principal Investigator.
- Active hepatitis B or C infection
- HIV 1 or 2 positivity
- Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
研究計画
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:ランダム化
- 介入モデル:並列代入
- 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:Stem cell transplant x 1 or x 2
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
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After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
他の名前:
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実験的:Continue lenalidomide and dexamethasone
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection
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Patients will then be randomized to continued Ld or high-dose melphalan with SCT.
On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT.
All patients after one or two SCT, will receive maintenance L.
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 |
時間枠 |
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Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
時間枠:2 years
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2 years
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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 |
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全生存
時間枠:4年まで
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4年まで
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Number of Participants With VGPR + CR Rate
時間枠:2 years
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VGPR/Very Good Partial Response + CR/Complete Response (>/= VGPR) for each study arm Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
2 years
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Overall Response Rates
時間枠:2 years
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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2 years
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協力者と研究者
捜査官
- 主任研究者:Hani Hassoun, MD、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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
- 免疫抑制剤
- 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
- 抗悪性腫瘍薬、アルキル化
- アルキル化剤
- 骨髄破壊的アゴニスト
- 血管新生阻害剤
- 血管新生調節剤
- 成長物質
- 成長阻害剤
- デキサメタゾン
- 酢酸デキサメタゾン
- BB1101
- レナリドミド
- メルファラン
その他の研究ID番号
- 08-121
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。
Stem cell transplant x 1 or x 2の臨床試験
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