A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel) with Lenalidomide (Revlimid) and Dexamethasone (Decadron) in Subjects with Relapsed and/or Refractory Multiple Myeloma - CA180-180

Bristol-Myers Squibb0 个研究点目标入组 9 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•- Subjects able to provide written informed consent
•- Subjects must have confirmed diagnosis of Multiple Myeloma with measure disease as described in section 4.2.1 point 2 of the protocol.
•- Subjects must have evidence of relapsed or refractory disease and have received at least 1 prior therapy for multiple myeloma
•- Subjects must have received last treatment (ie chemotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at least 21 days prior to treatment initiation.
•- ECOG performance status score 0-2
•- If subjects had a bone marrow transplant , this must be at least 3 months prior to treatment initiation
•- All acute toxicity of any prior therapy (radiotherapy, chemotherapy, or surgical procedures) must have resolved to Grade <2, NCI CTCAE, version 3.0
•- Adequate baseline laboratory results, refer to section 4.2.1 point 2 h of the protocol
•- Aged 18 years +
•-Women of child bearing potential (WOCBP) must be using an adequate method of contraception 4 weeks before the study, throughout the study and for at least 4 weeks after the last dose of investigational product.
•- WOCBP must have a negative serum or urine pregnancy test within 72 hours of the start of the study drug.

•- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study.
•- Women who are pregnant or breastfeeding
•- Women with a positive pregnancy test at enrolment or prior to study treatment
•- Men whose sexual partners are WOCBP who are unwilling or unable to use an accepted method of contraception throughout the study and for at least 4 weeks after discontinuing from the study.
•- Clinically significant cardiac disease (section 4.2.2 points a and b for examples)
•- Malabsorption syndrome or uncontrolled gastrointestinal toxicities (section 4.2.2. point c)
•- Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation.
•- Clinically significant pleural effusion in the previous 12 months or current ascitis
•- Clinically significant coagulation or platelet function disorder (eg, known von Willebrand*s disease).
•- Prior of concurrent malignancy (see exceptions in section 4.2.2 point g)
•- Intolerance to dasatinib and/or lenalidomide
•- medications that are generally considered to have a risk of causing *Torsades de Pointes*, refer to section 5.5.1.1 of the protocol.
•- Prisoners or subjects who are compulsory detained for treatment of either a psychiatric or physical illness must not be enrolled

发起方

Bristol-Myers Squibb