EUCTR2018-000924-32-DE进行中（未招募）1 期
Denosumab for high risk SMM and SLiM CRAB positive, early myeloma patients- a randomized, placebo controlled phase II trial DEFENCE” (DEnosumab For the rEductioN of the smoldering myeloma transformatioN inCidence ratE)
AGMT gGmbH0 个研究点目标入组 164 人开始时间: 2019年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- •Must meet criteria of high risk smoldering MM or early SLiM CRAB MM based on the criteria described below:
- •oHigh-risk SMM is defined here according to the Mayo Clinical criteria (2 out of 3 criteria must be fulfilled):
- •Bone marrow clonal plasma cells >20%
- •Serum M protein >2.0g/dL
- •Serum free light chain ratio >20 measured with Binding site Kit”
- •oEarly ‘SLiM CRAB’ multiple myeloma (3)
- •Patients must present with only one of the following features:
- •Bone marrow clonal plasma cells = 60%, or
- •Serum FLC ratio = 100 (k-LC leading) or = 0.01 (l-LC leading), measured with Binding site Kit”, or
- •>1 Focal bone lesion of =5mm (not associated with osteolysis, detected by PET-CT or whole-body low-dose CT (WBLDCT))
- •Time from diagnosis of high risk SMM or SLIM CRAB positive, early MM to study enrollment: <5 years
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •Active, symptomatic MM (fulfilling CRAB-criteria)
- •Non secretory MM, extramedullary plasmacytoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •Hypocalcemia (can be corrected by drug intervention before start of treatment)
- •Second malignancy within the past 5 years except:
- •oAdequately treated basal cell or squamous cell skin cancer
- •oCarcinoma in situ of the cervix
- •oProstate cancer Gleason score = 6 with stable prostate-specific antigen (PSA over 12 months)
- •oDuctal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- •oTreated medullary or papillary thyroid cancer
- •oSimilar condition with an expectation of > 95% five-year disease-free survival
- •Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
- •Patients with known active or latent tuberculosis
- •Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
- •Participation in another interventional study within the 28 days prior to randomization
- •Any other clinically significant medical disease or social condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent, be compliant with study procedures, or provide accurate information.
- •Prior administration of denosumab
- •Prior exposure to any experimental or approved anti-myeloma agent
- •Use of oral bisphosphonates with a cumulative exposure of more than 1 year (wash out period for allowed bisphosphonate exposure 1 month)
- •More than 1 previous dose of IV bisphosphonate or teriparatide administration (wash out period for allowed bisphosphonate exposure 1 month)
- •Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- •Active dental or jaw condition which requires oral surgery, including tooth extraction
- •Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
- •Female subject of child bearing potential is not willing to use, in combination with her partner, a highly effective and in addition an effective method of contraception during treatment and for 5 months after the end of treatment
- •Known sensitivity to denosunab (incl all components of the formulation) or any of the products to be administered during the study (eg, mammalian derived products, calcium, or vitamin D)
- •Subject is receiving or is less than 30 days since ending other experimental device or drug (no marketing authorization for any indication).
- •Subject will not be available for follow-up assessment
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