Phase 1 Clinical Trial of A Novel CDK Inhibitor Dinaciclib (SCH 727965) in Combination with Bortezomib and Dexamethasone in Relapsed Multiple Myeloma
Sheeba K. Thomas
The goal of this clinical research study is to find the highest tolerable dose of dinaciclib that can be given in combination with bortezomib and dexamethasone.
Treatment Location: N/A
Primary To determine the maximally tolerated doses of dinaciclib,dexamethasone, and bortezomib, when used in combination, in two different schedules, for treatment of relapsed multiple myeloma. Secondary To determine the toxicities associated with dinaciclib, dexamethasone, and bortezomib, when used in combination, for treatment of relapsed multiple myeloma. To determine the overall response rate associated with dinaciclib and bortezomib, when used in combination, for treatment of relapsed multiple myeloma. To explore the differences in toxicity associated with two different schedules of dinaciclib and bortezomib used in combination Correlative Research To examine if expression levels of target CDK: CDK 2,5,7 and 9 levels in CD138-purified tumor cells, will be correlated with response (clinical and molecular) to determine if high or low level target CDK expression, if present, influences dinaciclib efficacy. To examine if IgH translocation status, P53 status and presence of Myc amplification or rearrangement, determined on patient bone marrow before treatment, using a pre validated FISH panel to identify common myeloma translocations, will be correlated with molecular and/or clinical markers of drug activity, and to assess if specific genetic subgroups of myeloma tumors are responsive or resistant. To determine the gene expression profiles of myeloma cells before and after treatment to understand the role of tumor gene dysregulation and/or dinaciclib induced effects on transcription.
IRB Review and Approval Date: 07/17/2013
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Sheeba K. Thomas
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