CTRI/2019/08/020541进行中（未招募）3 期
Early versus delayed treatment in patients with biochemical relapse of multiple myeloma: a randomized phase III trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- JIPMER
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age =18 years
- •2.Patients diagnosed with active myeloma with biochemically measurable disease at time of diagnosis and have undergone primary therapy and achieved at least a partial response or better (as per the IMWG criteria for responses).
- •- Biochemically measurable disease at diagnosis would be defined as any one of the following
- •--Monoclonal spike by serum electrophoresis at least 0.5 g/dL
- •--Urine electrophoresis M protein of at least 500 mg in 24-hour sample
- •--Elevated serum free light chain with a ratio of at least 2 times the uninvolved light chain
- •3.Patients should have demonstrated evidence of biochemical relapse ? as defined as
- •a. Rise in serum M spike of at least 25% over nadir value with an absolute increase of at least 0.5g/dL
- •b. In case of patients with light chain only disease, there should be an increase of 25% in the dFLC (the difference in the absolute values of the involved and uninvolved light chains) from nadir dFLC.
- •4.No evidence of ongoing target organ damage at the time of randomisation
- •a. Hemoglobin >10g/dL
- •b. No evidence of new onset or increasing bone pains or new bone lesions or extramedullary plasmacytomas
- •c. Creatinine is < 2mg /dL and stable for at least 3 months
- •d. Normal serum calcium
- •e. No evidence of amyloid induced organ dysfunction
- •5.Number of previous lines of therapy should be only 1. For a transplant eligible patient, induction therapy, high dose therapy and auto transplantation, consolidation and maintenance/ continuation would be considered as 1 line of therapy. For a transplant ineligible patient, induction therapy followed by maintenance/ continuation (as defined below) would be considered as 1 line of therapy.
- •a. Maintenance ?: When a lower dose of medicine than usual is used. For example: Lenalidomide 10 mg per day or lesser or thalidomide 50 mg per day or bortezomib once in 2 weeks
- •b. Continuation ?: When the same initial doses (with or without steroids) is continued after initial therapy (Example: When Len 25 mg and Dex 40 mg weekly are continued till Progression as per data from the FIRST ? study or Bortezomib 2 mg weekly is continued or the original triplet regimen is continued as in a high risk patient)
- •6.Patients should have been on maintenance/ continuation therapy or observation after the initial line of therapy for at least 3 months prior to randomisation.
- •a. Accepted maintenance/ continuation therapies for trial inclusion are Thalidomide 50 -100 mg per day, lenalidomide 5-25 mg per day or Bortezomib 2mg once in 1-2 weeks.
排除标准
- •1. Patients with limited bone marrow involvement at diagnosis ( <10% plasma cells) and considered as myeloma only based on multiple plasmacytomas on imaging
- •2. CNS involvement by myeloma
- •3. Serious inter-current illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction that would preclude safe administration of the standard treatment.
- •4. Pregnancy in case of female patients
- •5. Lack of patient consent
- •6. Human Immunodeficiency Virus (HIV) infection/and or Anti-retroviral therapy and or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).
- •7. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HbeAg and HBV DNA titers must be negative and patients would be continued on appropariate prophylaxis with antivirals throughout the duration of the study).
- •8. History of allogeneic transplant
- •9. Patient with known peptic ulcer disease/ history of GI perforation due to peptic ulcer in the past.
- •10. Pre-existing peripheral neuropathy of > grade 1
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