NL-OMON50306已完成2 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 - CC-4047-MM-013 ; 0451/0116 ; POM013
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 (serum
- •M-protein * 0.5 g/dL or urine M-protein * 200 mg/24 hours)., 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., 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., b. Either commit to true
- •abstinence 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. Must practice true abstinence 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.
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/*L, b. Subject with platelet count
- •< 50,000/*L 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
- •*mol/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.
研究者
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