Phase 1
Completed N=35
Dasatinib in Combination With Revlimid (and Dexamethasone)
Source: ClinicalTrials.gov NCT00560391 ↗Enrolled (actual)
35
Serious AEs
45.7%
Results posted
Jul 2012
Primary outcomePrimary: Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) — 140; 25; 40 mg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) |
140; 25; 40 | — |
| PRIMARY Number of Participants With Dose-limiting Toxicity (DLT) |
1; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation |
3; 2; 0; 1; 3; 1 | — |
| PRIMARY Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia |
0; 2; 0; 1; 2; 1 | — |
| PRIMARY 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) |
4; 0; 2; 5; 5; 2 | — |
| PRIMARY Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus |
4; 2; 3; 4; 15; 1 | — |
| SECONDARY Number of Participants With Complete Response and Very Good Partial Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Partial Response |
1; 1; 2; 4; 3 | — |
| SECONDARY Number of Participants With Minimal Response |
0; 0; 0; 0; 0 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00560391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.