NCT03227432撤回2 期
An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Response Rate
研究概览
简要总结
This research study is studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM).
The drugs involved in this study are:
- Elotuzumab
- Nivolumab
- Pomalidomide
- Dexamethasone
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.
This study has two parts. Each part tests a different combination of drugs.
- In Part 1 participants will be given elotuzumab and nivolumab.
- In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and dexamethasone.
Each of these drugs works in a different way to help the body fight multiple myeloma. The drugs are being tested in different combinations to see if they are more effective when taken together.
Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA (the U.S. Food and Drug Administration) has approved elotuzumab in combination with lenalidomide as a treatment option for this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient ≥ age 18 years
- •Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- •Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
- •Patient must have received at least two previous lines of therapy for multiple myeloma including lenalidomide or thalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
- •Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
- •Serum M protein ≥ 0.5 g/dL (≥5 g/L)
- •Urine M protein ≥200 mg/24 hours
- •Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Appendix A)
- •Negative serum or urine pregnancy test for women of child-bearing potential
- •Screening Laboratory parameters:
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- •Platelet count ≥ 75,000 cells/dL (75 x 109/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- •Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
- •Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with known Gilbert Syndrome are allowed to have total bilirubin < 3.0 mg/dL)
- •Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 3.0x ULN
- •Estimated creatinine clearance by Cockcroft-Gault formula ≥ 40 mL/min
- •Serum creatinine < 1.5 X ULN. (Appendix C)
排除标准
- •Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- •Prior therapy with pomalidomide
- •Prior treatment with monoclonal antibodies including elotuzumab
- •Prior therapy with anti-programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) agents.
- •Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- •Prior anti-cancer therapy within 14 days.
- •Patient has any Grade 3 or > unresolved adverse reaction from previous treatment. Previous allogeneic stem cell transplantation with active graft-versus-host disease (GVHD) or being under immunosuppressive therapy in the last 2 months prior to inclusion in the trial.
- •Autologous stem cell transplant if < 12 weeks from enrollment.
- •Daily requirement for oral corticosteroids (equivalent to > 10 mg/day prednisone daily) Inhaled or topical corticosteroids are allowed.
- •Patient is human immunodeficiency virus (HIV) positive,.
- •Patient is Hepatitis B Surface antigen-positive.
- •Patient has active hepatitis C infection.
- •Patient has an autoimmune disease. (Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger).
- •Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.
- •History of erythema multiforme or severe hypersensitivity to prior IMiD's®
- •Inability to tolerate thromboprophylaxis
- •Known severe intolerance to prior steroid therapy (Grade 3 or above adverse event which was unresponsive to a dose reduction)
研究组 & 干预措施
Nivolumab + Elotuzumab
Experimental
- 22 patients will be entered, If > 4 patients achieve at least a partial response (PR) within 4 cycles an additional 18 patients will be treated.
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
干预措施: Elotuzumab (Drug)
Nivolumab + Elotuzumab
Experimental
- 22 patients will be entered, If > 4 patients achieve at least a partial response (PR) within 4 cycles an additional 18 patients will be treated.
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
干预措施: Nivolumab (Drug)
Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
Experimental
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
- Pomalidomide will be administered for 21 days per cycle
- Dexamethasone will be administered weekly
干预措施: Dexamethasone (Drug)
Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
Experimental
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
- Pomalidomide will be administered for 21 days per cycle
- Dexamethasone will be administered weekly
干预措施: Pomalidomide (Drug)
Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
Experimental
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
- Pomalidomide will be administered for 21 days per cycle
- Dexamethasone will be administered weekly
干预措施: Elotuzumab (Drug)
Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
Experimental
- Nivolumab will be administered intravenously twice per cycle for cycle 1-4
- Nivolumab will be administered intravenously once per cycle for cycle 5
- Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
- Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
- Elotuzumab will be administered intravenously once per cycle for cycle 5
- Pomalidomide will be administered for 21 days per cycle
- Dexamethasone will be administered weekly
干预措施: Nivolumab (Drug)
结局指标
主要结局
Response Rate
时间窗: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
次要结局
- Duration of Response(2 years)
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Time to Treatment Failure(2 years)
- Time to Response(2 years)
- The Rate of Clinical Benefit Response (CBR)(2 years)
研究者
Jacob Laubach
Principal Investigator
Dana-Farber Cancer Institute
研究点 (3)
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