Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
A Phase II Study of the Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
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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Cork、アイルランド
- Cork University Hospital
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Dublin、アイルランド
- Beaumont Hospital
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Dublin、アイルランド
- Mater Misericordiae University Hospital
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Dublin、アイルランド
- St James's Hospital
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Galway、アイルランド
- University Hospital Galway
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Limerick、アイルランド
- University Hospital Limerick
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Tullamore、アイルランド
- Midlands Regional Hospital
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Co Waterford
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Waterford、Co Waterford、アイルランド
- University Hospital Waterford
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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:
Participants must have a diagnosis of symptomatic MM, according to International Myeloma Foundation 2003 Diagnostic Criteria:
- Clonal plasma cells > 10% on bone marrow biopsy
- A monoclonal protein (paraprotein) in either serum or urine ( except in the cases of non-secretory myeloma).
If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
Evidence of end-organ damage felt related to the plasma cell disorder related organ or tissue impairment (ROTI), commonly referred to by the acronym 'CRAB':
- Hypercalcaemia: serum calcium (corrected for albumin) > 10.5mg/sL/>2.65mmol/L or upper limit of normal
- Renal insufficiency defined as serum creatinine > 2mg/sL/177μmol/L
- Anaemia: Normochromic, normocytic with a haemoglobin value > 2g/dL below the lower limit of normal or a haemoglobin < 10g/dL
- Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) as shown by CT scan and/or skeletal survey
Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma.
- Prior treatment of hypercalcaemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
- Bisphosphonates are permitted
- Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. Two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy.
- 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 subject at any time without prejudice to future medical care
- Age ≥ 18 years at the time of signing Informed Consent
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Lenalidomide Pregnancy Prevention Risk Management Plan. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Lenalidomide Pregnancy Prevention Risk Management Plan) and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory Lenalidomide Pregnancy Prevention Risk Management Plan, and be willing and able to comply with the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months)
- All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrolment
- Subject has an ECOG performance status of < 2 or Karnofsky performance status of ≥ 60 (Appendix E).
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Patient has ≥ Grade 2 peripheral neuropathy on clinical examination within 14 days before enrolment
- Renal insufficiency (serum creatinine levels > 2.5 mg/dL/221μmol/L, calculated creatinine clearance with Cockcroft-Gault formula (see Appendix G) < 45 ml/min)
- Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e. unable to maintain a platelet count 50,000 cells/mm3)
- Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria
- Subjects with a haemoglobin < 8.0 g/dL
- AST (SGOT) and ALT (SGPT) > 2 x ULN, bilirubin levels 1.5 ULN
- Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
- Myocardial infarction within 6 months prior to enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix G), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals)
- Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Female subject is pregnant or breast-feeding
- Serious psychiatric illness or addiction likely to interfere with participation in this clinical study
- Uncontrolled diabetes mellitus
- Contraindication to any required concomitant drugs or supportive therapies including hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity to acyclovir or similar anti-viral drug. History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dehydrate
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- Known seropositive for or active HIV infection or active hepatitis B or C viral infection. Patients who are seropositive because of hepatitis B virus vaccine are eligible
- Known intolerance to steroid therapy
- Patient has hypersensitivity to bortezomib, boron, or mannitol
- Diagnosed or treated for another malignancy within 2 years of enrolment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Participation in clinical trials with other anti-myeloma investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
- Radiation therapy within 2 weeks before randomization. Enrolment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
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: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:RsqVD
Oral lenalidomide 25mg days 1 - 14 of 21 day schedule Subcutaneous bortezomib 1.3mg/m2 days 1, 4, 8, 11 of 21 day schedule Oral dexamethasone 20mg on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day schedule
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25mg days 1 - 14 of 21 day schedule
他の名前:
1.3mg/m2 days 1, 4, 8, 11 of 21 day schedule
他の名前:
20mg on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day schedule
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 |
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To evaluate the overall response rate (ORR) after 4 induction cycles
時間枠:After 4 cycles (84 days)
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To evaluate the overall response rate (ORR) after 4 induction cycles and the best response to induction therapy with the combination of lenalidomide, subcutaneous (SQ) bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.
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After 4 cycles (84 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 |
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a) To evaluate the rate and severity of Peripheral Neuropathy (PN) of SQ bortezomib in combination with lenalidomide, and dexamethasone after the 4th and after the final cycle of induction therapy.
時間枠:After 4 cycles (84 days)
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Evaluate the rate and severity of Peripheral Neuropathy of SQ bortezomib in combination with lenalidomide, and dexamethasone after the 4th and after the final cycle of induction therapy
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After 4 cycles (84 days)
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Progression of disease
時間枠:Duration of the study, expected to be approximately 3 years
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Evaluate the time to progression
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Duration of the study, expected to be approximately 3 years
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Progression free survival
時間枠:Duration of the study, expected to be approximately 3 years
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Evaluate progression free survival
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Duration of the study, expected to be approximately 3 years
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Duration of response
時間枠:Duration of the study, expected to be approximately 3 years
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Duration of the study, expected to be approximately 3 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Peter O'Gorman, Dr、Mater Misericordiae University Hospital
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
その他の研究ID番号
- CTRIAL-IE (ICORG) 13-17
- 2013-005008-32 (EudraCT番号)
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