EUCTR2005-004937-16-PT进行中（未招募）不适用
Randomised, Controlled, Open-Label, Multi-Centre Comparison of Thalidomide Versus High-Dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 496
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
- •Patients must meet all of the following inclusion criteria to be eligible for enrolment and randomisation into the study:
- •·Male or female patients, aged = 18 years at the time of signing the informed consent form;
- •·Patients who have been previously diagnosed with MM (see Appendix 3 for the standard definition of MM), who have received between 1 and 3 prior lines of treatment for their disease (see Appendix 4 for definition of line of treatment), and who require therapy because of disease progression (see Appendix 1 for PD definition);
- •·Secretory MM with measurable levels of monoclonal protein in serum (> 10 g/L of IgG M protein or > 5 g/L of IgA M-protein) or urine (= 200 mg/24hours). Patient with the following rare subclasses of the immunoglobulin: IgD, IgE, IgM can be included in the study if the level of monoclonal protein in serum is > 5 g/L or = 200 mg/24hours in urine. As IgM immunoglobulin isotype can be related to Waldenstrom's macroglobulinemia, it is important to distinguish and not include in the study patients with Waldenstrom's macroglobulinemia;
- •·ECOG performance status of 0, 1, or 2 (see Appendix 5);
- •·Life expectancy > 3 months;
- •·Able to adhere to the study visit schedule and other protocol requirements;
- •·Women of child-bearing potential must agree to use 2 methods of contraception: 1 effective (for example hormonal or tubal ligation) and 1 barrier (for example latex condom, diaphragm) for at least 4 weeks before starting the therapy, during the Treatment Period, and for 4 weeks after the last dose;
- •·Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity during the Treatment Period and for 4 weeks after the last dose;
- •·Written, informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The presence of any of the following will exclude a patient from study enrolment:
- •·Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the Informed Consent Form (ICF);
- •·Pregnant or lactating women. A serum ß-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy);
- •·Non-secretory MM;
- •·Any of the following laboratory abnormalities:
- •-Absolute neutrophil count (ANC) < 500 cells/mm3 (0.5 x 109/L);
- •-Platelet count < 30,000/mm3 (30.0 x 109/L) without transfusion support within 7 days before the test;
- •-Serum creatinine > 3.0 mg/dL (265 µmol/L);
- •-Serum aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3.0 x upper limit of normal (ULN);
- •-Serum total bilirubin > 2.0 mg/dL (34 µmol/L);
- •·Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study;
- •·Severe cardiac dysfunction (according to the New York Heart Association [NYHA] classification III-IV [see Appendix 6]);
- •·Severe bradycardia (< 50 bpm);
- •·Peripheral neuropathy = Grade 2 in severity (according to the NCI CTC Version 3.0 – see Appendix 7);
- •·Prior history of malignancy (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of disease for = 5 years;
- •·Patient received any chemotherapy, corticosteroids (> 10 mg/day prednisone or equivalent as a continuous dose) within 4 weeks before randomisation;
- •·Previously treated with thalidomide or thalidomide derivatives;
- •·Patients refractory to high-dose dexamethasone (defined as experiencing less than a PR to dexamethasone, or PD within 6 months after discontinuing dexamethasone, or discontinued dexamethasone because of = Grade 3 dexamethasone-related toxicity. Previous high-dose dexamethasone therapy is defined as > 500 mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen);
- •·Contraindications for high-dose dexamethasone;
- •·Active or chronic gastrointestinal ulcers, active viral infections (herpes, varicella, HIV, hepatitis B, hepatitis C), glaucoma, uncontrolled hypertension, or diabetes mellitus, unless well controlled and under strict supervision during dexamethasone treatment;
- •·Patient enrolled in another clinical trial or who have participated in another trial within the last 4 weeks before randomisation.
研究者
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