EUCTR2013-001903-36-GR进行中（未招募）1 期
A PHASE 2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF POMALIDOMIDE (CC-4047) IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND MODERATE OR SEVERE RENAL IMPAIRMENT INCLUDING SUBJECTS UNDERGOING HEMODIALYSIS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Subjects must satisfy the following criteria to be enrolled in the study.
- •1. Must be = 18 years at the time of signing the informed consent form.
- •2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Subjects must have documented diagnosis of multiple myeloma and have measurable disease by M-protein (serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours) or by elevated measurable serum free light chain levels.
- •5. Subjects must have had at least 1 prior antimyeloma regimen including lenalidomide and documented progression as per the IMWG uniform response criteria (Durie, 2006) during or after the last antimyeloma regimen. Induction therapy followed by ASCT and consolidation/ maintenance will be considered as one regimen.
- •6. Subjects must have an impaired renal function with an estimated GFR of
- •< 45 mL/min/1.73 m2 according to the MDRD equation.
- •a. Impaired renal function must be due to multiple myeloma which needs to be
- •confirmed by kidney biopsy. A subject may be included without performing a kidney biopsy, if the procedure is not possible due to safety concerns. Furthermore, kidney biopsies may also be omitted, if there is no evidence of amyloidosis.
- •b. Subjects may have acute myeloma related renal failure or chronic myeloma related renal failure; they may also have been treated with dialysis before, including dialysis with high cut off membranes.
- •7. ECOG performance status score of 0, 1, or 2
- •8. Females of childbearing potential must:
- •a. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact. (Note: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- •b. Either commit to true abstinence (definition of true abstinence as in a.) from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
- •9. Male subjects must:
- •a. Practice true abstinence (Note: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Withdrawal and periodic abstinence of a female partner [eg, calendar, ovulation, symptothermal, post-ovulation methods] are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •The presence of any of the following will exclude a subject from enrollment
- •1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •3. Renal insufficiency due to other reasons than multiple myeloma or due to hypercalcaemia only.
- •4. Any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 1,000/µL
- •b. Subject with platelet count < 50,000/µL are not eligible regardless of the percentage of plasma cells in the bone marrow
- •c. Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- •d. Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
- •e. Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •f. Serum total bilirubin > 2.0 mg/dL (34.2 µmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia
- •5. Prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years; exceptions include the following:
- •a. Basal or squamous cell carcinoma of the skin
- •b. Carcinoma in situ of the cervix or breast
- •c. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •6. Previous therapy with pomalidomide.
- •7. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes = Grade 3 rash during prior thalidomide or lenalidomide therapy).
- •8. Peripheral neuropathy = Grade 2.
- •9. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
- •10. Subjects who are planning for or who are eligible for stem cell transplant.
- •11. Subjects with any one of the following:
- •a. Congestive heart failure (NY Heart Association Class III or IV)
- •b. Myocardial infarction within 12 months prior to starting study treatment
- •c. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- •12. Subjects who received any of the following within the last 14 days of initiation of study treatment:
- •a. Major surgery (kyphoplasty is not considered major surgery)
- •b. Use of any antimyeloma drug therapy
- •13. Use of any investigational agents within 28 days or five half-lives (whichever is longer) of treatment.
- •14. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
- •15. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
- •16. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form.
- •17. Pregnant or breastfeeding females.
- •18. Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B, or C or chronic hepatitis B or C, as well as any systemic infection without specific antimicrobial treatment.
- •19. Any condition that confounds the ability to interpret data from the study.
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