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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00560391
Registration number
NCT00560391
Ethics application status
Date submitted
16/11/2007
Date registered
19/11/2007
Date last updated
4/08/2016
Titles & IDs
Public title
Dasatinib in Combination With Revlimid (and Dexamethasone)
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Scientific title
A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma
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Secondary ID [1]
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CA180-180
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Treatment: Drugs - Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Treatment: Drugs - Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Treatment: Drugs - Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Treatment: Drugs - Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Experimental: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg - Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Experimental: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg - Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Experimental: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg - Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Experimental: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg - Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles.
Experimental: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg - Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.
Treatment: Drugs: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Treatment: Drugs: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Treatment: Drugs: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Treatment: Drugs: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
Treatment: Drugs: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
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Assessment method [1]
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The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.
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Timepoint [1]
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From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Primary outcome [2]
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Number of Participants With Dose-limiting Toxicity (DLT)
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Assessment method [2]
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DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination.
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Timepoint [2]
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From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Primary outcome [3]
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Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
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Assessment method [3]
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The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.
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Timepoint [3]
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From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Primary outcome [4]
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Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
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Assessment method [4]
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AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.
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Timepoint [4]
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Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Primary outcome [5]
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Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
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Assessment method [5]
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As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=<LLN(lower limit of normal)-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9/L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL; GR4:<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L; GR4:<25.0*10^9/L. BL=Baseline; PBL=post baseline.
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Timepoint [5]
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Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
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Primary outcome [6]
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Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
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Assessment method [6]
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Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline.
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Timepoint [6]
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Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
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Primary outcome [7]
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Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
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Assessment method [7]
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Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN - 8.0 mg/dL, GR2: <8.0 - 7.0 mg/dL, GR3: <7.0 - 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN - 11.5 mg/dL, GR2: >11.5 - 12.5 mg/dL, GR3: >12.5 - 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: <LLN - 1.2 mg/dL, GR2: <1.2 - 0.9 mg/dL, GR3: <0.9 - 0.7 mg/dL, GR4: <0.7 mg/dL. Phosphorus (low): GR1: <LLN - 2.5 mg/dL, GR2: <2.5 - 2.0 mg/dL, GR3: <2.0 - 1.0 mg/dL, GR4: <1.0 mg/dL. BL=Baseline; PBL=post baseline.
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Timepoint [7]
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Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
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Secondary outcome [1]
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Number of Participants With Complete Response and Very Good Partial Response
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Assessment method [1]
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Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour.
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Timepoint [1]
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Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Secondary outcome [2]
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Number of Participants With Partial Response
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Assessment method [2]
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Partial response was achieved when there was =50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by =90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a =50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, =50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was =30%; a =50% reduction in the size of soft tissue plasmacytomas was also required.
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Timepoint [2]
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Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Secondary outcome [3]
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Number of Participants With Minimal Response
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Assessment method [3]
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Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.
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Timepoint [3]
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Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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Eligibility
Key inclusion criteria
- Able to provide written informed consent
- Men and women age = 18 years
- Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within 1
month prior to treatment initiation
- Evidence of relapsed or refractory disease and at least one prior therapy for MM
- Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2
- Last MM treatment at least 21 days prior to treatment initiation• Bone marrow
transplant (BMT) at least 3 months prior to treatment initiation
- Required baseline hematology and chemistry parameters
- Resolution of acute toxicity due to prior therapy to Grade <2 per National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Women who are pregnant or breastfeeding
- Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who
are unwilling or unable to use an acceptable method to avoid pregnancy for the entire
study period and for at least one month (4 weeks) before and for at least one month (4
weeks) after the last dose of study medication.
- Clinically significant cardiac disease (New York Heart Association [NYHA] Class III or
IV)
- Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged (>
450 msec)
- Medications that are generally considered to have a risk of causing "Torsades de
Pointes"
- Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- Clinically significant pleural effusion in the previous 12 months or current ascites
- Clinically-significant coagulation or platelet function disorder
- Dementia, chronic medical or psychiatric condition, or laboratory abnormality
- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality, serious uncontrolled medical disorder or active infection
- Intolerance to dasatinib and/or lenalidomide
- Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis
related to prior thalidomide treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2012
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Prahran
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Recruitment postcode(s) [1]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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France
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State/province [2]
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Toulouse Cedex 03
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Country [3]
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France
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State/province [3]
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Vandoeuvre Les Nancy
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to determine the safety and tolerability of dasatinib when
given in combination with lenalidomide and a low dose dexamethasone for the treatment of
relapsed or refractory multiple myeloma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00560391
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00560391
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