Dovitinib Combined With Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01680796|
Recruitment Status : Withdrawn (The target drug, dovitinib, failed as a single agent in prior studies in patients with heavily treated multiple myeloma.)
First Posted : September 7, 2012
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Dovitinib Drug: Bortezomib Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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
- 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. ]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. ]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 ]Participants will be evaluated for time to first response, duration of response, time to best response, and time to disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680796
|Principal Investigator:||Jan S. Moreb, MD||University of Florida|