EUCTR2012-003023-38-DE进行中（未招募）1 期
Phase II study of Bortezomib, Melphalan, Prednisone (VMP) followed by Lenalidomide maintenance vs. VMP without maintenance in Myeloma patients not eligible to high-dose chemotherapy and autologous stem cell transplantation – a GERman MAINtenance study (GERMAIN)(GERMAIN) - German Maintenance Study – GERMAIN study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must understand and voluntarily sign an informed consent form.
- •2. Must be =18 years of age at the time of signing the informed consent form.
- •3. Must be able to adhere to the study visit schedule and other protocol requirements.
- •4. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
- •MM diagnostic criteria (all 3 required):
- •- Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma
- •- Monoclonal protein present in the serum and/or urine
- •- Myeloma-related organ dysfunction (at least one of the following):
- •[C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal)
- •[R] Renal insufficiency (serum creatinine >2 mg/dl)
- •[A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal)
- •[B] Lytic bone lesions or osteoporosis
- •AND have measurable disease by protein electrophoresis analyses as defined by the following:
- •IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level - 1.0 g/dl or urine M-protein level - 200 mg/24 hours
- •IgA multiple myeloma: Serum M-protein level - 0.5 g/dl or urine M-protein level - 200 mg/24 hours
- •IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0 g/dl or urine M-protein level = 200mg/24hours
- •IgD multiple myeloma: Serum M-protein level - 0.05 g/dl or urine M-protein level - 200 mg/24 hours
- •Light chain multiple myeloma: Serum M-protein level - 1.0 g/dl or urine M-protein level - 200 mg/24 hours
- •AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
- •The patient declines to undergo stem cell transplantation
- •Stem cell transplantation is not available to the patient
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •6. Female of childbearing potential (FCBP) must:
- •- Understand the potential teratogenic risk to the unborn child
- •- Understand the need for effective contraception, without interruption, 4 weeks before starting study treatment, throughout the entire duration of study treatment, dose interruption and 28 days after the end of study Treatment
- •- Understand and agree to inform the Investigator if a change or stop of method of contraception is needed.
- •- Be capable of complying with effective contraceptive measures and
- •agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the several time periods related to this study.
- •- Be informed about and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
- •- Agree to have two medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml prior to starting lenalidomide.
- •Male subjects must
- •- Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a FCBP
- •- Understand the need for the use of a condom and agree to use condoms even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a female of childbearing potential, while taking study drug, during any dose interruptions and for 28 days after stopping study therapy.
- •- Agree to notify the investigator immediately, if pregnancy or a positive pregnancy test occurs in his partner during study participation.
- •- Agree to abstain from d
排除标准
- •1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of Dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
- •2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
- •3. Pregnant or breast feeding females.
- •4. Any of the following laboratory abnormalities within 1 week prior to registration:
- •Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L) without the use of colony stimulating factors within 14 days before the laboratory test.Untransfused platelet count < 50,000 cells/µL (50 x 109/L)
- •Hemoglobin < 7.5 g/dL (4,6 mmol/L) (regardless of transfusion support or prior medication with erythropoietin)
- •Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- •5. Renal failure with CrCL< 15 ml/min and requiring hemodialysis or peritoneal dialysis.
- •6. Psychiatric illness that would prevent the subject from signing the informed consent form or from completion of treatment according to the protocol.
- •7. Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before registration.
- •8. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for 3 years. Exceptions include the following, if treated with curative intend:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •9. Known positive for HIV or active hepatitis A, B or C viral infection.
- •10. Immunotherapy or antibody therapy within 8 weeks before registration.
- •11. Major surgery within 4 weeks before registration.
- •12. Any severe systemic infection requiring treatment.
- •13. Patients who are unable or unwilling to undergo antithrombotic therapy.
- •14. Peripheral neuropathy of > grade 3 severity or grade 2 severity with pain.
- •15. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
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