A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Event-free Survival (EFS) Rate
研究概览
简要总结
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT.
Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of multiple myeloma.
- •Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.
- •Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids will not be considered treatment for multiple myeloma.
- •Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
- •Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently Day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment.
- •All US study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
- •Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
- •At least 18 and no more than 75 years of age at enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Normal bone marrow and organ function as defined as ALL of the following:
- •Absolute neutrophil count ≥ 1000/mm^3
- •Platelets ≥ 75,000/mm^3 (transfusions not permitted within 7 days of screening)
- •Total bilirubin ≤ 2.0 x institutional upper limit of normal (IULN)
- •AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- •Creatinine clearance ≥ 15 mL/min
- •Females of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document.
排除标准
- •Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or clinical relapse on therapy or within 60 days following completion of therapy. Prior exposure to elotuzumab and/or pomalidomide is allowed as long as patient is not refractory to these agents.
- •More than one prior transplant prior to study entry with the exception of tandem transplantation. Tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants.
- •Presence of peripheral neuropathy ≥ grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
- •History of plasma cell leukemia or MM central nervous system (CNS) involvement.
- •Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
- •Diagnosed with another concurrent malignancy requiring treatment.
- •Known HIV or active hepatitis A, B, or C. Antidoby testing not required for screening
- •Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
- •Receiving any other investigational agents within 14 days prior to enrollment.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Females of childbearing potential must have two negative pregnancy tests. The first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide.
研究组 & 干预措施
Elotuzumab + Pomalidomide + Dexamethasone
-
Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
-
Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
-
Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:
-
10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
-
2 mg pomalidomide daily on Days 1-21 of all cycles
-
40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+
-
Continuation therapy may continue until relapse or progression.
干预措施: Elotuzumab (Drug)
Elotuzumab + Pomalidomide + Dexamethasone
-
Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
-
Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
-
Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:
-
10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
-
2 mg pomalidomide daily on Days 1-21 of all cycles
-
40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+
-
Continuation therapy may continue until relapse or progression.
干预措施: Pomalidomide (Drug)
Elotuzumab + Pomalidomide + Dexamethasone
-
Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
-
Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
-
Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:
-
10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
-
2 mg pomalidomide daily on Days 1-21 of all cycles
-
40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+
-
Continuation therapy may continue until relapse or progression.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Event-free Survival (EFS) Rate
时间窗: 1 year
-Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.
次要结局
- Overall Response Rate (ORR)(1 year)
- Complete Response Rate (CRR)(1 year)
- Progression-free Survival (PFS)(Up to 5 years post completion of treatment)
- Overall Survival (OS)(Up to 5 years post completion of treatment)
- Toxicity of Regimen as Measured by Number of Grade 3-5 Adverse Events(Up to 30 days following completion of treatment (estimated to be 106 weeks))