NCT00560352 · REGISTRY CONDITION SEARCH

Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: TERMINATED
Registry last update: 2017-03-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone

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outcome · POSTED

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

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outcome · POSTED

Duration of Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

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

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outcome · POSTED

MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Key Inclusion Criteria: * Confirmed diagnosis of multiple myeloma with measurable disease * Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma * Eastern Cooperative Oncology Group Performance Status of 0 - 2 * Last treatment for multiple myeloma not within 21 days prior to study treatment initiation * Bone marrow transplant not within 3 months prior to study treatment initiation * Required baseline hematology and chemistry parameters. Key Exclusion Criteria: * Clinically significant cardiac disease (New York Heart Association Class III or IV) * Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (\>450 msec) after electrolytes have been corrected on baseline electrocardiogram * Malabsorption syndrome or uncontrolled gastrointestinal toxicities * Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * Clinically significant pleural effusion in the previous 12 months or current ascites * Clinically significant coagulation or platelet function disorder * Intolerance to dasatinib and/or bortezomib * Acute diffuse infiltrative pulmonary disease * Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Phase I dose escalation study
intervention Names
Drug: Dasatinib
Drug: Bortezomib
Drug: Dexamethasone
label
Dasatinib + Bortezomib + Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Dasatinib + Bortezomib + Dexamethasone
description
Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD
name
Dasatinib
other Names
Sprycel
BMS-354825
type
DRUG
arm Group Labels
Dasatinib + Bortezomib + Dexamethasone
description
Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD
name
Bortezomib
other Names
Velcade®
type
DRUG
arm Group Labels
Dasatinib + Bortezomib + Dexamethasone
description
Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
time Frame
Days 1 to 21
description
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.
measure
MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone
time Frame
Days 1 to 21

secondary Outcomes

description
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.
measure
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)
description
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.
measure
Duration of Response
time Frame
First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)
description
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.
measure
Progression-free Survival
time Frame
Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
description
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.
measure
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)

Full study description

brief Summary: 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.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice