KRd consolidation in myeloma patients with a positive PET-CT after standard first line treatment. A phase II study - CONPET

Oslo University Hospital0 个研究点目标入组 50 人开始时间: 2020年10月30日最近更新: 2021年4月5日

研究概览

暂无简介。

•1. Prior confirmed diagnosis of multiple myeloma (2014).
•2. Received standard first line treatment with at least partial response. Standard first line treatment is defined as VRD, VTD or VCD followed by ASCT, with or without lenalidomide maintenance
•3. Carfilzomib naïve
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•5. Absolute neutrophil count (ANC) = 0,5 x 109/L and platelet count >35 x 109/L.
•6. At least very good partial remission (VGPR) from first line treatment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Change of first line treatment because of stabile or progressive disease.
•2. Major surgery within 28 days before enrollment.
•3. Radiotherapy within 14 days before enrollment.
•4. Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
•5. Patients who started treatment more than 12 month before screening
•6. Central nervous system involvement.
•7. Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
•8. Uncontrolled hypertension or uncontrolled diabetes despite medication
•9. Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
•10. Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
•11. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
•12. Not expected to tolerate full dose KRd

发起方

Oslo University Hospital