2024-514702-31-00
尚未招募
2 期
Daratumumab in combination with Carfilzomib, Pomalidomide and Dexamethasone (DCPD) in patients with multiple myeloma induced acute renal failure - "Time is Kidney in the Treatment of myeloma Cast nephropathy" The TIKTAC phase II trial (Pilot-study)
Medizinische Universitaet Innsbruck1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月29日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Medizinische Universitaet Innsbruck
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dialysis dependent patients: To determine the rate of patients becoming dialysis independent after induction treatment in patients with myeloma induced renal failure requiring dialysis and receiving induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)
概览
简要总结
To determine the safety and toxicity and the rate of renal recovery in newly diagnosed patients with multiple myeloma induced renal failure receiving daratumumab in combination with carfilzomib, pomalidomide and dexamethasone for 4 cycles.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients in need of therapy with untreated multiple myeloma and myeloma induced renal failure either requiring dialysis, or with renal insufficiency with an estimated creatinine clearance <30 ml/min.
- •Disease free of prior malignancies for ≥ 2 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast if they have undergone complete resection.
- •Female patients who Are older than 50 years and postmenopausal for at least 1 year before the screening visit, OR
- •Female patients who Are surgically sterile, OR
- •Female patients who If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from 4 weeks before starting study therapy through 90 days after the last dose of study drug, OR
- •Female patients who Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- •Female patients who Are informed and understand the possible consequences of the teratogenic potential of pomalidomide
- •Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug
- •Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
- •Male patients are informed and understand the possible consequences of the teratogenic potential of pomalidomide
排除标准
- •Female patients who are lactating or have a positive serum pregnancy test during the screening period
- •Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- •Known gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of difficulty swallowing.
- •Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast with are not excluded if they have undergone complete resection
- •Patient has ≥ grade 3 peripheral neuropathy
- •Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
- •Pre-existing documented severe renal impairment (before suspected MM diagnosis) with an eGFR of <30 ml/min/1.73 m
- •Previous anti-myeloma treatment within the last 21 days prior to baseline visit (cycle 1 / day 1), except corticosteroid therapy (<=160 mg dexamethasone or corticosteroid dose equivalent for a maximum of 5 days prior to d1c1)
- •Major surgery within 14 days before enrollment
- •Radiotherapy within 14 days before enrollment, except local radiation for pain and/or instable bones
结局指标
主要结局
Dialysis dependent patients: To determine the rate of patients becoming dialysis independent after induction treatment in patients with myeloma induced renal failure requiring dialysis and receiving induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)
Dialysis dependent patients: To determine the rate of patients becoming dialysis independent after induction treatment in patients with myeloma induced renal failure requiring dialysis and receiving induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)
Patients not dialysis dependent: To determine the rate of patients achieving improvement of their renal function after induction treatment. Patients receive induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)renal recovery
Patients not dialysis dependent: To determine the rate of patients achieving improvement of their renal function after induction treatment. Patients receive induction treatment with 4 cycles of daratumumab in combination with carfilzomib, pomalidomide and dexamethasone (DCPD)renal recovery
次要结局
- Progression free survival at 1 year (PFS)in months, defined as the time from day 1 of cycle 1 to the date of first documentation of disease progression based on IMWG criteria or death due to any cause, whichever occurs first.
- Overall response rate (ORR) being described as complete response, near complete response, very good partial response, partial response, minor response, stable disease, progressive disease. ORR will be assessed according to International Myeloma Working Group (IMWG) criteria, including Minor Response (MR) according to European Society for Blood and Bone Marrow Transplantation (EBMT) criteria
- Time to first response defined as days from day 1 of cycle 1 to the first documented response
- Time to best response defined (days) from day 1 of cycle 1 to the best documented response
- Recording of AE´s, SAE´s, ECOG performance status, assessment of clinical laboratory values.
- Minimal residual disease will be performed in bone marrow samples (only in patients achieving complete response after cycle 4) according to the Euroflow-protocol (FACS-Analysis) with a sensitivity of 10-5)
研究者
University Hospital for Internal Medicine V
Scientific
Medizinische Universitaet Innsbruck
研究点 (1)
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