An open-label, multi-center, Phase I-Ib/II study of AUY922 administered as single agent and in combination with bortezomib with or without dexamethasone in adult patients with relapsed or refractory multiple myeloma

ovartis Pharma Services AG0 个研究点目标入组 74 人开始时间: 2008年5月27日最近更新: 2012年10月22日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: ovartis Pharma Services AG
入组人数: 74

研究概览入排标准研究者记录与标识符相似试验

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

•Inclusion criteria
•1.Patients must have a diagnosis of active MM according to the International Myeloma Working Group criteria (Durie et al. 2006):
••Presence of an M-component in serum or urine (in patients with no detectable M-component, an abnormal FLC ratio on the serum FLC assay can substitute this criteria),
•Clonal Plasma cells in the bone marrow (= 10% of clonal plasma cells) and/or documented clonal plasmacytoma,
•PLUS one or more of the following attributable to plasma cell disorder at the time of diagnosis:
•Calcium elevation (?11.5 mg/dl),
•Renal insufficiency (Creatinine ? 2 mg/dl),
•Anemia (Hemoglobin ? 10g/dl or 2g/dl ? normal),
•Bone disease (lytic lesions or osteopenia).
•2.AUY922 single agent (Phase I dose escalation & Phase II dose expansion parts)
•Patients with relapsed-refractory MM (please refer to Post-text supplement 2) who received at least two but no more than three prior anti-myeloma regimens had progressed during or after the last therapy.
•Prior therapy must include at least one of the following: bortezomib or lenalidomide or thalidomide.
•Induction therapy followed by any kind of stem cell transplantation and/or maintenance therapy is considered as 1 regimen.
•AUY922 in combination (Phase Ib dose escalation part)
•Patients with relapsed-refractory MM (please refer to Post-text supplement 2) who received no more than two prior anti-myeloma regimens (excluding dexamethasone as single agent).
•Patients must be suitable (according to their local product information) for treatment with bortezomib. Note: patients previously treated with lenalidomide or thalidomide are eligible to participate in the trial.
•Induction therapy followed by any kind of stem cell transplantation and/or maintenance therapy is considered as 1 regimen.
•5.Age = 18 years.
•6.ECOG Performance Status of = 2.
•7.Life expectancy of = 12 weeks.
•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.Patients with non-secretory MM.
•2.Patients who have received allogenic stem cell transplantation ? 12 months prior to enter in the study.
•3.Patients who have received allogenic stem cell transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
•4.Patients with unresolved diarrhea = CTCAE grade 2.
•5.Patients with acute or chronic liver disease.
•6.Peripheral neuropathy = CTCAE grade 1 (only for patients in the combination part of the study).
•7.Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
•8.Pregnant or lactating women.
•9.Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception.
•10.Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

研究者

发起方

ovartis Pharma Services AG

相似试验

进行中（未招募）

1 期

A first-in-human clinical trial in adult patients with metastatic or recurrent melanoma of a personalised therapy targeting specific mutations that occur in all cancer cells within a single patient.

EUCTR2018-003446-16-DEAchilles Therapeutics UK Limited40

进行中（未招募）

1 期

A first-in-human clinical trial in adult patients with metastatic or recurrent melanoma of a personalised therapy targeting specific mutations that occur in all cancer cells within a single patient.

EUCTR2018-003446-16-ESAchilles Therapeutics UK Limited40

招募中

1 期

CTIS2024-513060-26-00Achilles Therapeutics UK Limited50

进行中（未招募）

1 期

EUCTR2018-003446-16-GBAchilles Therapeutics Limited40

招募中

1 期

CTIS2024-513062-19-00Achilles Therapeutics UK Limited40