EUCTR2014-000268-17-ES进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA
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
- 559
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 be >= 18 years
- •2. Understand and voluntarily sign an informed consent document
- •3. Adhere to the study visit schedule and other protocol requirements.
- •4. Diagnosis of multiple myeloma and have measurable disease by serum or urine protein electrophoresis (sPEP or uPEP): sPEP >= 0.5 g/dL or uPEP >= 200 mg/24 hours.
- •5. At least 1 but no greater than 3 prior anti-myeloma regimens.
- •6. Documented disease progression during or after their last anti-myeloma therapy.
- •7. Must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles.
- •8. ECOG 0, 1, or 2.
- •9. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 4 weeks before starting study treatment, while participating in the study (including dose interruptions), and for at least 4 weeks after study treatment discontinuation, and must agree to regular pregnancy testing during this timeframe.
- •10. Females must agree to abstain from breastfeeding during study participation and 4 weeks after study treatment discontinuation.
- •11. Males must agree to use a latex or synthetic condom
- •12. Males must also agree to refrain from donating sperm
- •13. All subjects must agree to refrain from donating blood
- •14. All subjects must agree not to share medication.
- •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 352
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 430
排除标准
- •1. Subjects who had documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule
- •2. Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization
- •3. Non-secretory multiple myeloma
- •4. Abnormal lab values (see protocol):
- •5. Subjects with severe renal impairment (Creatinine Clearance [CrCl] <30 mL/min) requiring dialysis
- •6. Subjects with prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following non-invasive malignancies (see protocol)
- •7. Previous therapy with pomalidomide
- •8. History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, bortezomib, boron, mannitol, or dexamethasone
- •9. >= Grade 3 rash during prior thalidomide or lenalidomide therapy
- •10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
- •11. Subjects with any one of the following (see protocolo)
- •12. Subjects who received any of the following within the last 14 days of initiation of study treatment (see protocol)
- •13. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
- •See protocol for the rest of exclusion criteria
研究者
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