EUCTR2008-003753-33-IT进行中（未招募）1 期
?An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma? Protocol 095-00 - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 142
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
入选标准
- •SUBJECT/PATIENT INCLUSION CRITERIA
- •A patient must satisfy each of the following criteria in order to qualify for participation in
- •1. Patient, or the patient?s legal representative, has voluntarily agreed to participate by
- •giving written informed consent. For those institutions that do not allow a legal
- •representative to provide consent on behalf of a patient, patients must be able to
- •provide written informed consent for themselves.
- •2. Patient is ≥18 years of age on the day of signing informed consent.
- •3. Patient has an established diagnosis of multiple myeloma based on myeloma
- •diagnostic criteria located in Appendix 6.5 [10; 11].
- •4. Patient has relapsed and refractory multiple myeloma after at least 2 prior treatment
- •regimens as per the EBMT response criteria located in Appendix 6.6 [12] and meets
- •both of the following conditions:
- •Refractory to Bortezomib (administered either alone or in combination with
- •other agents); defined as no response on prior bortezomib-containing regimens
- •or progression on or within 60 days of a bortezomib-containing regimen.
- •Relapsed, refractory, intolerant, and/or ineligible (in the opinion of the
- •Investigator) to other therapies, including an IMiD (thalidomide OR
- •lenalidomide).
- •5. Patient must have performance status of ≤ 2 on the ECOG Performance Scale located
- •in Appendix 6.7 [13].
- •6. Patient has measurable disease, defined as any quantifiable serum M-protein value
- •and, where applicable, urine light chain of ≥200 mg/24 hours.
- •7. Female patient of childbearing potential must have a negative serum pregnancy test
- •within 7 days prior to first dose of study drug.
- •8. Female patient of childbearing potential is willing to use 2 adequate barrier methods
- •of contraception to prevent pregnancy or agrees to abstain from heterosexual activity
- •throughout the study, starting with Visit 1 through 30 days after the last dose of study
- •drug. Adequate contraceptive methods include for example, intra-uterine device,
- •diaphragm with spermicide, cervical cap with spermicide, or female condom with
- •spermicide. Spermicides alone are not an acceptable method of contraception.
- •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
- •SUBJECT/PATIENT EXCLUSION CRITERIA
- •A patient meeting any of the following criteria is not eligible to participate in the study:
- •1. Patient has had any prior allogeneic bone marrow transplant (patient with prior
- •autologous transplant is eligible).
- •2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or
- •autologous) within 4 weeks after initiating study therapy.
- •3. Patient had prior treatment with vorinostat or other HDAC inhibitors (e.g.,
- •depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781,
- •etc.). Patients who have received compounds with HDAC inhibitor-like activity, such
- •as valproic acid, as anti-tumor therapy should not be enrolled in this study. Patients
- •who have received such compounds for other indications, e.g. valproic acid for
- •epilepsy, may enroll after a 30-day washout period.
- •4. Patient was unable to tolerate prior treatment with bortezomib.
研究者
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