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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD
Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
Orlando Health, Inc. M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Local Institution
Nantes, Cedex 1, France
Local Institution
Lille, France
Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
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.
Time frame: Days 1 to 21
MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone
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.
Time frame: Days 1 to 21
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
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.
Time frame: Day 1 until last tumor assessment (maximum reached: 9 months)
Duration of Response
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution
Bari, Italy
Local Institution
Bologna, Italy
Local Institution
Salamanca, Spain
Time frame: First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)
Progression-free Survival
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.
Time frame: Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
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
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.
Time frame: Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)