Clinical trial · Interventional
Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT00560352CI-TRIAL-00026398terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib + Bortezomib + Dexamethasone
- description
- Phase I dose escalation study
- interventionNames
- Drug: Dasatinib
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
- timeFrame
- 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 MTD is the maximum dose that the participants received.
- measure
- MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.