Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma RelapseAn Australian Myeloma Forum Multi-Centre Phase II Trial to improve time to progression

Peter MacCallum Cancer Centre0 个研究点目标入组 100 人开始时间: 2006年5月16日最近更新: 2020年1月13日

适应症

试验速览

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•1.Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or third line therapy. Patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.2. Patient is of a legally consenting age, as defined by local regulations.3. Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.4. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.5. Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.6. Male patient agrees to use an acceptable method for contraception for the duration of the study.7. Patient has measurable disease8. Patient has a Karnofsky performance status =60%.9. Patient has a life-expectancy >3 months.

•1. Primary Dexamethasone resistancePatients are defined as being refractory to treatment with high-dose dexamethasone if they achieved less than a partial response, or developed progressive disease within 6 months of discontinuing dexamethasone, or dexamethasone was discontinued because of =Grade 3 dexamethasone-related toxicity.oHigh-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen.2.Prior therapy with Bortezomib3.Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol4. Neuropathy > Grade 2.

发起方

Peter MacCallum Cancer Centre