Multiple MyelomaPhase 1NCT00560391

Dasatinib in Combination With Revlimid (and Dexamethasone)

A Phase 1 study testing Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg, Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg and Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg in people with Multiple Myeloma, run by Bristol-Myers Squibb at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg, Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg and Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 4 sitesin 3 countries
Study dates: May 2008to Nov 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

France2 sites

Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54511

Other trials in France

United States1 site

Mayo Clinic Arizona
Scottsdale, Arizona, 85259

Other trials in United States

Australia1 site

Local Institution
Prahran, Victoria, 3181

Other trials in Australia

About this study

Official 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

Conditions: Multiple Myeloma
Being tested: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg, Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg, Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg, Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg, Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mgDrug
Also called Sprycel®, BMS-354825, Revlimid®
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.
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgDrug
Also called Sprycel®, BMS-354825, Revlimid®
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.
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgDrug
Also called Sprycel®, BMS-354825, Revlimid®
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.
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgDrug
Also called Sprycel®, BMS-354825, Revlimid®
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.
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgDrug
Also called Sprycel®, BMS-354825, Revlimid®
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.

Study groups in NCT00560391
Study group	Role	What they receive
Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg	Experimental	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. Receives: Drug: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg	Experimental	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. Receives: Drug: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg	Experimental	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. Receives: Drug: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg	Experimental	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. Receives: Drug: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg	Experimental	Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles. Receives: Drug: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
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.
Measured: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants With Dose-limiting Toxicity (DLT)
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.
Measured: 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]).
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
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.
Measured: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
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.
Measured: 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]).
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
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.
Measured: 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])
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)
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.
Measured: 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])
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
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.
Measured: 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])

Secondary outcomes (3)

Number of Participants With Complete Response and Very Good Partial Response
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.
Measured: Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants With Partial Response
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.
Measured: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants With Minimal Response
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.
Measured: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Nov 2012

First posted19 Nov 2007 (estimated)
Study startMay 2008
Primary completionOct 2011
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00560391
Sponsor's protocol ID: CA180-180
Status last verified: Nov 2013
First submitted: 16 Nov 2007
Last updated: 4 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00560391
Acronym / sponsor ID: CA180-180
Conditions: Multiple Myeloma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Oct 2011 (actual)
Study completion: Nov 2012 (actual)
First posted: 19 Nov 2007 (estimated)
Results: Posted 20 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg	Experimental	Drug: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mgParticipants 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.
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg	Experimental	Drug: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgParticipants 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.
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg	Experimental	Drug: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgParticipants 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.
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg	Experimental	Drug: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgParticipants 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.
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg	Experimental	Drug: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgParticipants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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"

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mgAlso: Sprycel®, BMS-354825, Revlimid®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.	Drug	Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgAlso: Sprycel®, BMS-354825, Revlimid®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.	Drug	Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mgAlso: Sprycel®, BMS-354825, Revlimid®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.	Drug	Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgAlso: Sprycel®, BMS-354825, Revlimid®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.	Drug	Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mgAlso: Sprycel®, BMS-354825, Revlimid®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.	Drug	Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg

Primary outcome

Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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.
Number of Participants With Dose-limiting Toxicity (DLT)
Time frame: 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]).
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.
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
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.
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
Time frame: 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]).
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.
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Time frame: 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])
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.
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)
Time frame: 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])
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.
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Time frame: 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])
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.

3 secondary outcomes

Number of Participants With Complete Response and Very Good Partial Response
Time frame: Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants With Partial Response
Time frame: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Number of Participants With Minimal Response
Time frame: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Results and safety

Results posted to the registry on 20 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg	6	6
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg	3	3
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg	3	3
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg	6	5
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg	17	15

Primary outcome: Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)

Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).. Number. Unit: mg

Measure	All Treated Participants n = 35
RP2D of dasatinib in the combination	140
RP2D of lenalidomide in the combination	25
RP2D dexamethasone in the combination	40

Population analysed: All treated participants, participants who received at least 1 dose of dasatinib.

Primary outcome: Number of Participants With Dose-limiting Toxicity (DLT)

Time frame: 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]).. Number. Unit: participants

Measure	Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg n = 6	Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 6	Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 4
Value	1	0	0	1	0

Population analysed: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)

Primary outcome: Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone

Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).. Number. Unit: participants

Measure	Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg n = 6	Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 6	Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 4
Value	0	0	0	0	0

Population analysed: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)

Primary outcome: Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation

Time frame: 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]).. Number. Unit: participants

Measure	Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg n = 6	Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg n = 3	Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 6	Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg n = 17
All deaths	3	2	0	1	3
Deaths within 30 days of last dose	1	1	0	0	2
All SAEs	3	2	2	5	9
Drug-related SAEs	1	1	1	1	4
AEs leading to discontinuation	2	1	1	1	8
Drug-related AEs leading to discontinuation	2	0	0	0	7
All AEs	6	3	3	6	17
Drug-related AEs	6	3	3	6	17

Population analysed: All treated participants, participants who received at least 1 dose of dasatinib.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg	9 of 17 (52.9%)	17 of 17 (100%)	Not reported
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) (time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.