EUCTR2008-000411-15-GR进行中（未招募）1 期
A Phase Ib multicenter dose-determination study, with an adaptive, randomized, placebo-controlled, double-blind phase II, using various repeated IV doses of BHQ880 in combination with zoledronic acid in relapsed or refractory myeloma patients with prior skeletal-related event. - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Relapsed or refractory multiple myeloma patients requiring treatment with a nonbortezomib-
- •containing regimen (prior treatment with bortezomib is acceptable)
- •2. The diagnosis of symptomatic multiple myeloma as defined by the following criteria
- •(International Myeloma Working Group):
- •M-protein in serum or urine
- •Clonal bone marrow plasma cells or plasmacytoma
- •Presence of related organ or tissue impairment (ROTI)
- •3. Patients with multiple myeloma who do not have measurable serum M-protein or
- •measurable urine M-protein must have measurable increased concentrations of free light
- •chains (using FreeLite™)
- •4. At least one prior SRE defined as one of the following:
- •Pathologic fracture
- •Spinal cord compression
- •Requirement for either radiation or surgery to bone due to:
- •- Prevention of imminent fracture
- •- Stabilization of a fracture
- •5. Stable renal function defined as two serum creatinine determinations of < 2.5 mg/dl or
- •calculated (Cockroft-Gault formula) creatinine clearance (CrCl) < 60 mL/min.
- •Cockcroft-Gault formula (Cockcroft and Gault 1976):
- •CrCl = [140-age (years)] x weight (kg) (x 0.85 for female patients)
- •[72 x serum creatinine (mg/dL)]
- •6. Current or planned treatment with zoledronic acid
- •7. No symptoms of hyperviscosity, amyloidosis or recurrent infection
- •8. Corrected serum calcium < 12 mg/dl or ionized calcium < 6.5 mg/dL within 14 days prior
- •to registration
- •9. Life expectancy of at least 12 months.
- •10. Ambulatory patients aged 18 years or older
- •11. ECOG performance status = 2
- •12. Absolute neutrophil count = 1500/mm3
- •13. Platelet count = 75,000/mm3
- •14. Hemoglobin (Hgb) = 9 g/dl (prior RBC transfusion, recombinant epoetin alfa, or
- •darbepoetin alfa allowed)
- •15. Electrolyte levels = LLN (i.e., potassium, magnesium, phosphorus) correction with
- •supplements allowed
- •16. AST and ALT = 2.5 x ULN
- •17. Serum bilirubin = 1.5 x ULN
- •18. Patients must sign the informed consent form and be willing and able to comply with the
- •study 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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known concomitant disease(s) known to influence Ca2+ metabolism including
- •hyperparathyroidism, hyperthyroidism and/or Paget’s disease of bone.
- •2. Current active dental problems including
- •Ongoing infection of the teeth or jawbone
- •Current exposed bone in the mouth
- •Dental or fixture trauma
- •Current or previous osteonecrosis of the jaw
- •Slow healing after dental procedures
- •Recent (within 6 weeks) or planned dental or jaw surgery during the study
- •3. Prior radiation therapy to treat diseases of the mouth
- •4. Patients who are allergic to/ intolerant of bisphosphonate therapy
- •5. Acute or chronic liver disease
- •6. Patients with any peripheral neuropathy = CTCAE grade 2
- •7. Other concurrent severe and/or uncontrolled concomitant medical conditions that could
- •cause unacceptable safety risks or compromise compliance with the protocol
- •8. Angina pectoris = 3 months prior to starting study drug
- •9. Acute myocardial infarction = 6 months prior to starting study drug
- •10. LVEF < 45%
- •11. Other clinically significant heart disease
- •12. A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
- •13. Patients who have not recovered from significant grade 3-4 side effects of previous antimyeloma therapy
- •14. Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
- •15. Patients who have received any investigational drug = 5 half lives prior to starting study drug or who have not recovered from side effects of such therapy. Or patients who have received previous investigational monoclonal antibody or radioimmunotherapy drug = 60 days prior to starting study drug or who have not recovered from side effects of such
- •16. Known diagnosis of human immunodeficiency virus (HIV) infection
- •17. Women of child-bearing potential (WCBP) who are pregnant or breast feeding. WCBP, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 24 consecutive months (i.e., who have had menses any time in the preceding 24 consecutive months), must have a negative serum pregnancy test = 48 hours prior to starting study treatment. In addition, all sexually active WCBP and male patients must agree to use adequate contraceptive methods (oral,
- •injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device;
- •barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
- •18. Patients with a history of another primary malignancy that is currently clinically
- •significant or currently requires active intervention
- •19. Patients unwilling or unable to comply with the protocol
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