Self-administration of Subcutaneous Elranatamab in the Patients' Homes. An Open Label, Phase Two, Prospective, Multi-center, Non-randomized, Sponsor-initiated Explorative Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist
研究概览
简要总结
The goal of this open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial is to test self-administration of subcutaneous Elranatamab in the patients' homes in patients with relapsed multiple myeloma exposed to at least one proteasome inhibitor, one IMID and one anti CD-38 antibody. The main question[s]it aims to answer are:
- To evaluate the safety of self-administration of Elranatamab in the patients' own homes using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.
- To evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes by registration of discarded doses, planned doses administered at home and doses diverted from the patients' homes to the outpatient clinic.
- To elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home by interviewing both parties at end of treatment (EOT).
- To elucidate the perspectives of involved healthcare professionals in a focus group interview at end of study (EOS).
- To clarify time spent on self-administration at home compared to administration at the outpatient clinic by registering time consumption for patients, caregivers and healthcare professionals.
- To evaluate the patients' QoL during self-administration using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT Cognitive).
- To clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole by weekly registration of any unplanned contacts.
- To determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system by collecting data on lost earnings, transport costs and salary costs.
- To evaluate the feasibility of the use of an electronic registration of side effects prior to treatment by comparing electronic patient reported outcome (PRO) data to registrations performed by nurses in the outpatient clinic during telephone consultations.
Participants will be asked to
- register time spend
- answer PRO-questionnaires
- weekly register any unplanned contact to the heathcare system
- be interviewed
详细描述
Background Bispecific antibodies targeting CD3 and BCMA have demonstrated astonishing efficacy with response rates of nearly 65 % in triple class exposed patients with multiple myeloma (MM). This will not necessarily be the first product to be marketed, but might be a product proven to be applicable for safe and convenient self-administration in the patients' homes, thereby improving the patients' and their caregivers' Quality of Life (QoL) and reducing the burden on the healthcare system. Although optimal dosing regimens are still being investigated, most CD3xBCMA are given weekly until progression, with the possibility of downscaling to twice monthly, if good remission is obtained. Consequently, patients have multiple visits to the outpatient clinic, meaning that they spend a substantial amount of time on transport, and that they are continuously exposed to potential infections. Furthermore, the outpatient clinic might end out with many bispecific treatments in the future, due to their high efficiency, thus straining the logistics of the hospital.
Previous studies have shown that patients who administer their treatment themselves experience better QoL, a higher level of well-being, and have a higher level of daily activity. In addition, socio-economic savings of up to 20-50% are seen with self-administration compared to outpatient treatment.
Elranatamab is a bispecific CD3xBCMA with some unique properties; it is given subcutaneously as a fixed dose, and it has shown a remarkably low risk of CRS after the third injection. This makes it a perfect candidate to investigate in a setup, where patients are trained in self-administration at their own homes.
Acquiring source data and planned visits In the study, Elranatamab will be administered as monotherapy for six cycles of 28 days (Table 1). Patients will receive subcutaneous Elranatamab 76 mg QW with a 2-step-up priming dose regimen administered during the first week (12 mg D1 and 32 mg D4). For safety reasons, the step-up doses will be administered with hospitalization for a minimum of 48hr (C1D1) and 24hr (C1D4), respectively. During hospitalization, vital signs will be measured at least 6 times per overnight stay. If treatment is tolerated, C1D8, C1D15 and C1D22 will be administered in the outpatient clinic and will include training of the patients in self-administration. In cycle 2 to cycle 6, patients will administer the treatment themselves in the outpatient clinic D1 and at home D8, D15 and D22. However, if patients experience any CRS during the study, the consecutive two doses must be administered in the outpatient clinic without any signs of CRS, before home treatment can be resumed. If patients experience ICANS, they will be taken off study.
Prior to each new treatment cycle, laboratory assessments will be conducted at the local hospital or at the patient's GP, according to general standards. A hematologist at Odense University Hospital, who will also evaluate the patient, must accept the laboratory assessments before D1 of all cycles.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age at the time of signing the informed consent form.
- •Relapsed MM according to the IMWG criteria.
- •Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) and/or Serum free light chain (FLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in patients without measurable disease in the serum or urine.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or
- •Previously exposed to at least two of the following; one proteasome inhibitor, one IMID, or one anti CD-38 antibody.
- •Documented disease progression during or after last anti-myeloma regimen.
- •Possibility of being observed by a capable caregiver during self-administration.
- •ANC ≥1.0 x 109/L (G-CSF allowed).
- •Platelets ≥25 x 109/L.
- •Female patients of childbearing potential must have a negative serum pregnancy test at screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
排除标准
- •Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
- •Prior history of ICANS.
- •Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes and metastasis] clinical staging system) or prostate cancer that is curative
- •Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically significant Amyloidosis.
- •Female who is pregnant, breastfeeding or who intends to become pregnant during the participation in the study.
- •Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C.
- •Resident on an unbridged island.
- •Not being able to register PRO-data electronically.
研究组 & 干预措施
Self-administration of Elranatamab
It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.
干预措施: Elranatamab (Drug)
结局指标
主要结局
Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist
时间窗: approximately 24 weeks
Registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.
次要结局
- evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes(approximately 24 weeks)
- elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home(approximately 1 hour)
- elucidate the perspectives of involved healthcare professionals(approximately 2 hours)
- evaluate the patients' QoL during self-administration(approximately 24 weeks)
- clarify time spent on self-administration at home compared to administration at the outpatient clinic(approximately 24 weeks)
- clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole(approximately 24 weeks)
- determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system(approximately 24 weeks)
- evaluate the feasibility of the use of an electronic registration of side effects prior to treatment(approximately 24 weeks)
研究者
Thomas Lund
Principal Investigator
Odense University Hospital