Skip to content
Triangle logo TriangleGet started
← Study library

NCT00560391 · REGISTRY CONDITION SEARCH

Dasatinib in Combination With Revlimid (and Dexamethasone)

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
COMPLETED
Registry last update
2016-08-04

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.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

Number of Participants With Dose-limiting Toxicity (DLT)

→

outcome · POSTED

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

→

outcome · POSTED

Number of Participants With Complete Response and Very Good Partial Response

→

outcome · POSTED

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

→

outcome · POSTED

Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia

→

outcome · POSTED

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)

→

outcome · POSTED

Number of Participants With Partial Response

→

outcome · POSTED

Number of Participants With Minimal Response

→

outcome · POSTED

Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
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 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
    label
    Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    label
    Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Drug: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    label
    Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Drug: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    label
    Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    type
    EXPERIMENTAL
  5. description
    Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.
    intervention Names
    1. Drug: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    label
    Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
    description
    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.
    name
    Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
    other Names
    1. Sprycel®
    2. BMS-354825
    3. Revlimid®
    type
    DRUG
  2. arm Group Labels
    1. Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    description
    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.
    name
    Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    other Names
    1. Sprycel®
    2. BMS-354825
    3. Revlimid®
    type
    DRUG
  3. arm Group Labels
    1. Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    description
    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.
    name
    Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
    other Names
    1. Sprycel®
    2. BMS-354825
    3. Revlimid®
    type
    DRUG
  4. arm Group Labels
    1. Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    description
    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.
    name
    Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    other Names
    1. Sprycel®
    2. BMS-354825
    3. Revlimid®
    type
    DRUG
  5. arm Group Labels
    1. Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    description
    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.
    name
    Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
    other Names
    1. Sprycel®
    2. BMS-354825
    3. Revlimid®
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
35
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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]).
  2. description
    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.
    measure
    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]).
  3. description
    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.
    measure
    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]).
  4. description
    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.
    measure
    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]).
  5. description
    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.
    measure
    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])
  6. description
    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.
    measure
    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])
  7. description
    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.
    measure
    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])
secondary Outcomes
  1. description
    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.
    measure
    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]).
  2. description
    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.
    measure
    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]).
  3. description
    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.
    measure
    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]).
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-0ed98face374929ff367
      requested nct id
      NCT00560391
      primary nct id
      NCT00560391
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      fa9ab044454932627ebff8dcf0a2e1d8938894feb805e4dc2043c0679530763e
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-0ed98face374929ff367
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00560391
      occurrences
      1. context exact
        NCT00560391
        end
        11
        exact text
        NCT00560391
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/916/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      f7b45685692149f7a6877db32f7f5671a7bf407ab08370b3187f8124e3420d22

    Preserved source evidence · Not medical advice