Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Overall Response Rate
研究概览
简要总结
Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.
详细描述
Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.
This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active, symptomatic multiple myeloma without prior chemotherapy:
- •Durie-Salmon Stage II-III A/B
- •Stage I patients with at least 2 of the poor prognostic indicators may be eligible.
- •Patients with plasma cell leukemia
- •Non-secretory multiple myeloma patients are eligible
- •Patients between the ages of 18 and 75 years old
- •Female Patients of child bearing age (up to age 50) who are not pregnant and agree to use two adequate birth control methods during the study and at least six months after treatment unless patient has undergone hysterectomy or has been in menopause for 2 years.
- •Patients with Southwest Oncology Group (SWOG) performance status of 3 or better
- •Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as adjunct to radiation therapy for cord compression may be eligible
- •All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater than or equal to 50% within 42 days prior to registration
- •Must be able to understand English.
- •Must be willing and eligible to sign up for the STEPS program
排除标准
- •Nursing mothers or women who are pregnant
- •Patients with a history of hypersensitivity reaction to doxorubicin or agents in Doxil®
- •Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years.
- •History of mediastinal radiation for any reason
- •History of receiving prior anthracyclines
- •Patients with uncontrolled medical problems such as diabetes mellitus, cardiac, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma
- •Myocardial infarction within 6 months of enrollment in the study.
- •Major surgery within 4 weeks of enrollment.
- •Patients previously treated or receiving other treatment for multiple myeloma other than lower doses dexamethasone as adjunct to radiotherapy
- •Pre-existing peripheral neuropathy
- •Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities of the gastrointestinal tract that result in malabsorption syndromes.
- •Patients with a history of cardiac disease, defined as New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
- •Patients with psychiatric or central nervous systems disorders interfering with compliance of orally administered medication.
- •Patients currently receiving anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states.
- •Patients who are unable to understand the English language.
研究组 & 干预措施
1
Doxil, Thalidomide, Dexamethasone
干预措施: Doxil (Drug)
1
Doxil, Thalidomide, Dexamethasone
干预措施: Thalidomide (Drug)
1
Doxil, Thalidomide, Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: At End of Cycle 1, 28 Days
Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
次要结局
- Toxicity(End of study, up to 12 months)