EUCTR2016-001209-17-ES进行中（未招募）1 期
A PHASE 2, MULTICENTER, OPEN-LABEL, STUDY TO DETERMINE THE SAFETY AND EFFICACY FOR THE COMBINATION OF DURVALUMAB (DURVA) AND DARATUMUMAB (DARA) (D2) IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (FUSION MM-003) - FUSION MM-003
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
- 144
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. Subject received at least 3 prior anti-myeloma regimen including a PI and an immunomodulatory agent or is double-refractory to a PI and an immunomodulatory agent.
- •· Induction, bone marrow transplant with or without maintenance therapy is considered one regimen.
- •· Refractory is defined as disease that is nonresponsive on therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy.
- •· For subjects who received more than 1 regimen containing a PI their disease must be refractory to the most recent PI containing regimen.
- •· For subjects who received more than 1 regimen containing a immunomodulatory agent their disease must be refractory to the most recent immunomodulatory agent containing regimen.
- •2. Subject has measurable disease defined as:
- •a. M-protein (serum protein electrophoresis (sPEP) or urine protein electrophoresis (uPEP): sPEP = 0.5 g/dL or uPEP = 200 mg/24 hours) and/or
- •b. Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- •3. Subject achieved a response (MR or better) to at least 1 prior treatment regimen.
- •4. Subject has evidence of PD on or within 60 days of the most recent prior treatment regimen.
- •5. Subject received an alkylating agent alone or in combination with other myeloma treatment.
- •6. Subject has an Eastern Cooperative Oncology Group performance-status score of 2 or less.
- •7. Subject’s toxicities resulting from previous therapy (including peripheral neuropathy) have resolved or stabilized to = Grade 1.
- •8. Subject is at least 18 years of age at the time of signing the informed consent form (ICF).
- •9. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- •10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •11. Females of childbearing potential (FCBP ) must:
- •a. Have 2 negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
- •b. Either practice true abstinence2 from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for at least 90 days after discontinuation of study treatment.
- •c. Refrain from egg cell donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.
- •12. Male subjects must:
- •a. Either practice true abstinence (which must be reviewed on a monthly basis) 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 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy.
- •b. Refrain from sperm donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years
排除标准
- •1. Subject has had prior exposure to anti-CTLA-4, anti-PD-1, anti-PD-L1 mAbs, cell-based therapies, or cancer vaccines
- •2. Subject received DARA or other anti-CD38 therapies previously
- •3. Subject received any of the following within the last 14 days of initiating study treatment:
- •a. Plasmapheresis
- •b. Major surgery (as defined by the investigator)
- •c. Radiation therapy other than local therapy for myeloma associated bone lesions
- •c. Use of any systemic anti-myeloma drug therapy
- •4. Subject received prior treatment with a monoclonal antibody within 5 half-lives of initiating study treatment
- •5. Subject used any investigational agents within 28 days or 5 half-lives of initiating study treatment
- •6. Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment
- •7. History of organ or allogeneic stem cell transplantation
- •8. Subject has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization
- •9. Subject has any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 1,000/µL
- •b. Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to reach this level)
- •c. Hemoglobin < 8 g/dL (< 4.9 mmol/L)(it is not permissible to transfuse a subject to reach this level)
- •d. Creatinine Clearance (CrCl) < 45 mL/min
- •e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
- •f. Serum aspartate aminotransferase (AST) or alanine aminotransferase(ALT) > 2.5 × upper limit of normal (ULN)
- •g. Serum total bilirubin > 1.5 × upper limit of normal (ULN) or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome
- •10. Subject has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS MM
- •11. Subject has known COPD with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
- •12. Subject has known moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification
- •13. Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis
- •14. Subject has nonsecretory MM
- •15. Subject has known allergy or hypersensitivity to study drug formulations
- •16. Subject has active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
- •a. Subjects with vitiligo or alopecia.
- •b. Subjects with hypothyroidism stable on hormone replacement.
- •c. Psoriasis not requiring systemic treatment.
- •17. Subject has history of primary immunodeficiency
- •18. Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
- •19. Subject has received live, attenuated vaccine within 30 days prior to the first dose of DURVA
- •20. Subject is currently using or has used immunosuppressive medication within 14 days prior to the first study dose of study treatment. The following are exceptions to this criterion:
- •a. Intranasal, inhaled, or local steroid injections
- •b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- •c. Steroids as premedication for hypersensitivity reactions
- •21. Subject has any one of the following:
- •a. Clinically significant abnormal ECG finding at screening
- •b. Congestive heart failure
- •c. Myocardial infarction within 12 months prior to starting study treatment
- •d. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pecto
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