Dovitinib Combined With Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma
This is an open-label phase I study in which dovitinib is given in combination with bortezomib and dexamethasone. Dovitinib dose escalation is planned in order to determine its maximum tolerated dose when given in this combination.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I, Open Label, Clinical Study to Determine the Maximum Tolerated Dose (MTD) of Oral Dovitinib (TKI258) When Given in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma Patients|
- Evaluate the safety and dose-limiting toxicity of treatment with dovitinib in combination with bortezomib/ dexamethasone. [ Time Frame: Treatment Cycle 1 (three weeks) for each participant. ] [ Designated as safety issue: Yes ]Determination of the maximum tolerated dose of dovitinib will be based on Treatment Cycle 1 safety data for all subjects for whom all safety assessments during Treatment Cycle 1, as well as the pre-dosing safety assessments performed on Study Day 1 of Treatment Cycle 2, are completed and who do not receive alternate anti-neoplastic therapies during that period.
- To assess the overall response rate for the combination dovitinib/bortezomib/ dexamethasone in patients receiving at least 4 cycles of therapy. [ Time Frame: Participants will be followed for up to one year. ] [ Designated as safety issue: No ]Starting with Treatment Cycle 2, response to treatment will be determined during each treatment cycle (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), and Stable Disease (SD)).
- Other Secondary Efficacy Objectives [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Participants will be evaluated for time to first response, duration of response, time to best response, and time to disease progression.
|Study Start Date:||February 2013|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Active Treatment
Dovitinib will be given at up to four different dose levels beginning with dose level 1 on a 5 days on/2 days off dosing schedule of each 21-day cycle.
Bortezomib will be given at two different dose levels intravenously on Days 1 and 8 of each 21-day cycle.
Dexamethasone will be given orally on Days 1, 2, 8, and 9 of each 21-day cycle.
Dose Level 0: 200 mg daily
Dose Level 1: 300 mg daily
Dose Level 2: 300 mg daily
Dose Level 3: 400 mg daily
Dose Level 4: 500 mg daily
Other Name: TKI258Drug: Bortezomib
Dose Level 0: 1.3 mg/m2 IV on days 1 and 8
Dose Level 1: 1.3 mg/m2 IV on days 1 and 8
Dose Level 2: 1.6 mg/m2 IV on days 1 and 8
Dose Level 3: 1.6 mg/m2 IV on days 1 and 8
Dose Level 4: 1.6 mg/m2 IV on days 1 and 8
Other Name: VelcadeDrug: Dexamethasone
Dexamethasone 20 mg will be given orally on Days 1, 2, 8, and 9 of each 21-day cycle.
Other Name: Decadron
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680796
|Principal Investigator:||Jan S. Moreb, MD||University of Florida|