Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
This study has been terminated.
Information provided by (Responsible Party):
First received: November 16, 2007
Last updated: July 23, 2012
Last verified: July 2012
The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma|
Resource links provided by NLM:
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Bortezomib DasatinibU.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone [ Time Frame: Days 1 to 21 ] [ Designated as safety issue: Yes ]MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.
- MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone [ Time Frame: Days 1 to 21 ] [ Designated as safety issue: Yes ]MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.
Secondary Outcome Measures:
- Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry [ Time Frame: Day 1 until last tumor assessment (maximum reached: 9 months) ] [ Designated as safety issue: No ]S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.
- Duration of Response [ Time Frame: First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) ] [ Designated as safety issue: No ]Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first.
- Progression-free Survival [ Time Frame: Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) ] [ Designated as safety issue: No ]Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.
- Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade [ Time Frame: Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) ] [ Designated as safety issue: Yes ]An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.
|Study Start Date:||February 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Dasatinib + Bortezomib + Dexamethasone
Phase I dose escalation study
Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
Other Names:Drug: Bortezomib
Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m^2 QD, 1.3 mg/m^2 QD
Other Name: Velcade®Drug: Dexamethasone
Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560352
|United States, Florida|
|Orlando Health, Inc. M.D. Anderson Cancer Center Orlando|
|Orlando, Florida, United States, 32806|
|United States, Georgia|
|Winship Cancer Institute, Emory University|
|Atlanta, Georgia, United States, 30322|
|Nantes, Cedex 1, France, 44093|
|Lille Cedex, France, 59037|
|Bari, Italy, 70124|
|Bologna, Italy, 40138|
|Salamanca, Spain, 37007|
Sponsors and Collaborators
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|