NCT05572229招募中2 期
A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
University Hospital, Lille29 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年12月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 29
- 主要终点
- Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len
研究概览
简要总结
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients
This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below:
- •Multiple myeloma diagnosis according to IMWG diagnostic criteria
- •Measurable disease at Screening as defined by any of the following:
- •Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio
- •Have an ECOG performance status score of 0-2
- •Not considered for high-dose chemotherapy and autologous SCT
- •Have clinical laboratory values meeting the criteria during the Screening Phase.
- •A male patient must wear a condom (with spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a period of 3 months after the last dose of other study treatments, whichever occurs later. If the male patient's partner is a female of childbearing potential, she must also be practicing a highly effective method of contraception. If the male patient is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
- •7. A male patient must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for period of 3 months after receiving the last dose of other study treatments, whichever occurs later.
- •8. Must sign an ICF (or their legally acceptable representative must sign in accordance with local requirements) indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •9. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •Medical Conditions
- •CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- •Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.
- •Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma).
- •Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy
- •Any active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
- •Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
- •Presence of the a cardiac conditions.
- •Tec-Dara-specific
- •COPD with a FEV1 <50% of predicted normal. Note that FEV1 testing is required for patients with known or suspected of having COPD or asthma and patients must be excluded if FEV1 <50% of predicted normal.
- •Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that FEV1 testing is required for patients known or suspected asthma and patients must be excluded if FEV1 <50% of predicted normal.
- •Prior/Concomitant Therapy
- •Radiotherapy within 14 days or focal radiation within 7 days.
- •Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14-days before the first dose of study drug (does not include pretreatment medications).
- •Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) are allowed.
- •Any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids prior to signing ICF (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent).
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- •Diagnostic Assessments
- •HIV positive.
- •Hepatitis B infection.
- •Active hepatitis C infection as measured by positive HCV-RNA testing. Other Exclusions
- •Women of childbearing potential
- •Patient had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery., or has major surgery planned during the time the patient is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- •Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results.
- •Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study intervention.
- •Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.
研究组 & 干预措施
Tec-Dara
Experimental
For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
干预措施: Teclistamab (Drug)
Tec-Dara
Experimental
For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
干预措施: Daratumumab (Drug)
Tec-Len
Experimental
For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity
干预措施: Teclistamab (Drug)
Tec-Len
Experimental
For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len
时间窗: At the end of 4 th cycle (each cycle is 28 days), an average 4 months
次要结局
- Overall response rate(PR or better) as defined by the IMWG response criteria(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Time to response(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Very good partial response or better, defined as VGPR or CR according to the IMWG criteria at the time of data cutoff(TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Complete response or better, defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow*(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- TTNT, defined as the time from date of the first dose of study treatment to the start of the next-line treatmentTime-to-next treatment(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Rate of Sustained MRD-negativity-(at level of 10-5 and 10-6 by NGS)(at 18 months (12 months after the initial MRD time point).)
- Duration of response(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Rate of minimal residual disease (MRD)-negativity (at level of 10-5 and 10-6 by NGS) at 6 months(at 6 months)
- Treatment-emergent adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0).(From date of randomization until the date of first documented progression,assessed up to 5 years)
- Overall survival time(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- TTTF, defined as the time from the date of the first dose of study treatment to discontinuation of therapy for any reason including death, progression, toxicity(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
研究者
研究点 (29)
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