EUCTR2006-000026-31-AT进行中（未招募）不适用
Bevacizumab as treatment for patients with relapsed/refractory multiple myeloma - Avastin in MM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
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
- •1. Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters. Measurable secretory disease defined as either:
- •- Quantifiable serum monoclonal immunoglobulin > 1 g/dl for IgG, > 0.5 g/dl for IgA or > 0.05 g/dl for IgD
- •- Measurable urine levels of Bence-Jones protein (> 200mg/24 hours)
- •2. Progressive disease after 2 lines of prior therapy: This includes progressive disease after an initial response (complete, partial or minimal) to a salvage regimen or progression during such therapy. A single line of therapy may consist of one or more cytotoxic/biological agents such as melphalan plus prednisone; vincristine plus adriamycin plus dexamethasone (VAD); pulsed high-dose dexamethasone; thalidomide + dexamethasone; bortezomib. A single line of therapy is also defined as induction therapy (such as VAD) followed by high-dose melphalan with autologous stem cell transplantation plus maintenance treatment.
- •Progressive disease as defined by one of the following criteria:
- •- > 25% increase in M-protein
- •- development of new or worsening lytic bone lesions
- •- development of new or worsening plasmacytoma
- •- development of new or worsening hypercalcemia despite appropriate medical treatment
- •3. Age 19 – 80 years.
- •4. ECOG performance status 0 or 1 or 2.
- •5. Life expectancy greater than 3 months.
- •6. At the time of screening, hematologic values within the following limits:
- •- Absolute neutrophil count >/= 1’000/µl
- •- Platelet count >/= 75’000/µl
- •- Hemoglobin >/= 8.0 g/dl without transfusion support for 7 days
- •7. Adequate liver function:
- •- AST/ALT < 2.5 x ULN
- •- Serum bilirubin < 1.5 xULN
- •8. Adequate renal function:
- •- Creatinine clearance of >/= 30 ml/min
- •9. Urinalysis: Urine dipstick of proteinuria < 2+. Patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate < 1 g of protein / 24 hours
- •10. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of enrolment. Patients not receiving anti coagulant medication must have an INR 11. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. Fertile women and men of childbearing potential (< 2 years after last menstruation in women) should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
- •12. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures.
- •13. Patient must be able to comply with the protocol
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Non-secretory myeloma
- •2. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
- •3. Clinical or radiological evidence of CNS involvement or spinal cord compression.
- •4. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
- •5. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:
- •- Basal and squamous cell carcinoma of the skin
- •- In-situ carcinoma of the cervix
- •6 Serious non-healing wound, ulcer or bone fracture.
- •7. Evidence of any severe active acute or chronic infection.
- •8. Evidence of bleeding diathesis or coagulopathy.
- •9. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
- •10 Uncontrolled hypertension
- •11. Chronic, daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
- •12. Treatment with any investigational drug or participation in another investigational study within 30 days prior to enrolment.
- •13. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •14. A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drug.
- •15. HIV-positive, Hbs-antigen positive or HCV-RNA-positive patients.
- •16. Pregnancy (positive serum pregnancy test) and lactation.
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