NCT02833610已完成2 期
A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Percent Change Of sCTX Levels
研究概览
简要总结
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
详细描述
This research study is a Phase II clinical trial. This study will assess the safety and tolerability of denosumab in Multiple Myeloma participants, by studying drug interactions with different parts of the body.
The FDA (the U.S. Food and Drug Administration) has not approved Denosumab for this specific disease but it has been approved denosumab for use in other cancers to treat cancer-related bone disease such as prostate and breast cancer.
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
- •Patients with symptomatic MM as defined by IMWG requiring anti-myeloma therapy.
- •Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
- •Monoclonal protein present in the serum and/or urine
- •Creatinine clearance < 30 mL/min, not eligible for bisphosphonate. Estimated glomerular filtration rate will be calculated using Cockcroft-Gault equation.
- •Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL)
- •Able to tolerate daily supplementation of calcium and vitamin D
- •Vitamin D level ≥ 30 ng/mL after repletion
- •Participants must have normal organ as defined below:
- •Total bilirubin ≤ 2.0 x ULN
- •AST(SGOT) ≤2.5 × institutional upper limit of normal
- •ALT(SGPT) ≤2.5 × institutional upper limit of normal
- •Plan to receive anti-myeloma therapies.
- •Age ≥ 18 years.
- •ECOG performance status ≤ 2
- •Life expectancy greater than 6 months
- •0-3 lines of prior anti-myeloma therapy.
- •Subjects with reproductive potential must be willing to use, in combination with his/her partner, 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after the study duration. Subjects who are surgically sterile (e.g. history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g. history of vasectomy) are not required to use additional contraceptive measures.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior administration of denosumab.
- •Active IV bisphosphonate use in the last 3 months.
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •Plasma cell leukemia.
- •Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
- •Active dental or jaw condition which requires oral surgery, including tooth extraction.
- •Non-healed dental/oral surgery, including tooth extraction.
- •Planned invasive dental procedures during the course of study.
- •Evidence of any of the following conditions per subject self-report or medical chart review
- •Any prior invasive malignancy within 5 years of enrollment that may affect outcome of study
- •Any non-invasive malignancy not treated with curative intent or with known active disease within 5 years before enrollment that may affect outcome of study
- •Major surgery or significant traumatic injury occurring within 4 weeks before enrollment
- •Active infection with Hepatitis B virus or Hepatitis C virus
- •known infection with human immunodeficiency virus (HIV)
- •Active infection requiring IV anti-infective therapy
- •Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment.
- •Female subject of child-bearing potential is not willing to use, in combination with her partner, 2 methods of highly effective contraception during treatment and for 5 months after the end of treatment.
- •Clinically significant hypersensitivity to denosumab 120 mg.
- •Known sensitivity to any of the products to be administered during the study (e.g. calcium, or vitamin D).
- •Subject is receiving or is less than 14 days since ending other experimental drug (no marketing authorization for any indication).
- •Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
研究组 & 干预措施
Denosumab Injection
Experimental
Patients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection.
干预措施: Denosumab Q4W (Drug)
结局指标
主要结局
Percent Change Of sCTX Levels
时间窗: 2 years
次要结局
- Percent Change In Bone Mineral Density(2 years)
- Percent Change In uNTX Levels(2 years)
- Subject Incidence Of Hypocalcemia(2 years)
- Subject Incidence Of Occurrence Of Documented SRE At 12 Months(2 years)
- Subject Incidence Of Adverse Events(2 years)
- Percent Change In Bone Turnover Markers(2 years)
研究者
Andrew Yee, MD
Principal Investigator
Massachusetts General Hospital
研究点 (7)
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