Trial · NCT00560352
Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
NCT00560352, Phase 1, Terminated, Bristol-Myers Squibb; results first posted 2012-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma. Trials, record NCT00560352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00560352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
- NCT number
- NCT00560352
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Multiple Myeloma
- Interventions
- Dasatinib, Bortezomib, Dexamethasone
- First posted
- 2007-11-19
- Last updated
- 2017-03-13
- Results first posted
- 2012-07-09
- Limitations and caveats
- The study was terminated due to an unexpectedly low recruitment rate, and no participants were enrolled in a planned dose-expansion phase.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | Days 1 to 21 | 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. |
| Primary | MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | Days 1 to 21 | 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 dose is the maximum dose that the participants received. |
| Secondary | Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Day 1 until last tumor assessment (maximum reached: 9 months) | S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP\<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein \<200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to \<50% drop in S MP and ≥50% to \<90% drop in U MP and ≥25% to \<50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia. |
| Secondary | Duration of Response | First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) | Duration of response calculated for those with best response=CR (M-protein \[MP\] undetectable by immunofixation \[IF\], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum \[S\] MP and urine \[U\] MP\<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein \<200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to \<50% drop in S MP and ≥50% to \<90% drop in U MP and ≥25% to \<50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first. |
| Secondary | Progression-free Survival | Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) | Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population. |
| Secondary | Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade | Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | Days 1 to 21 | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | mg QD | NUMBER |
| SECONDARY | Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Day 1 until last tumor assessment (maximum reached: 9 months) | All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response | First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months) | All response-evaluable participants who achieved a response. | Months | NUMBER |
| SECONDARY | Progression-free Survival | Day 1 to disease progression or death, whichever came first (maximum reached: 14 months) | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | Months | MEDIAN |
| SECONDARY | Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade | Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months) | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone. | Participants | NUMBER |
| PRIMARY | MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone | Days 1 to 21 | All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone | mg/m^2 | NUMBER |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | All Treated | MTD dasatinib | NA | mg QD | |
| Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone | All Treated | Recommended MTD dasatinib | 140 | mg QD | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 50 mg BID | Complete response (CR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 100 mg QD | Complete response (CR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 140 mg QD | Complete response (CR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 50 mg BID | Very good partial response (VGPR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 100 mg QD | Very good partial response (VGPR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 140 mg QD | Very good partial response (VGPR) | 0 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 50 mg BID | Partial response (PR) | 14.3 | Percentage of participants | |
| Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry | Dasatinib, 100 mg QD | Partial response (PR) | 0 | Percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, 50 mg BID | 7 | |
| Overall Study | STARTED | Dasatinib, 100 mg QD | 3 | |
| Overall Study | STARTED | Dasatinib, 140 mg QD | 4 | |
| Overall Study | COMPLETED | Dasatinib, 50 mg BID | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg QD | 0 | |
| Overall Study | COMPLETED | Dasatinib, 140 mg QD | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib, 50 mg BID | 7 | |
| Overall Study | NOT COMPLETED | Dasatinib, 100 mg QD | 3 | |
| Overall Study | NOT COMPLETED | Dasatinib, 140 mg QD | 4 |
Source ClinicalTrials.gov
Adverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib, 100 mg QD | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib, 140 mg QD | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib, 50 mg BID | 2 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dasatinib, 100 mg QD | 2 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dasatinib, 140 mg QD | 1 | 4 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dasatinib, 50 mg BID | 1 | 7 | |
| other | Angina pectoris | Cardiac disorders | Dasatinib, 100 mg QD | 0 | 3 | |
| other | Angina pectoris | Cardiac disorders | Dasatinib, 140 mg QD | 1 | 4 | |
| other | Angina pectoris | Cardiac disorders | Dasatinib, 50 mg BID | 0 | 7 | |
| other | Abdominal pain | Gastrointestinal disorders | Dasatinib, 100 mg QD | 1 | 3 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 100 mg QD | ||
| Total, all-cause mortality | Dasatinib, 140 mg QD | ||
| Total, all-cause mortality | Dasatinib, 50 mg BID | ||
| Total, other adverse events | Dasatinib, 100 mg QD | 3 | 3 |
| Total, other adverse events | Dasatinib, 140 mg QD | 4 | 4 |
| Total, other adverse events | Dasatinib, 50 mg BID | 6 | 7 |
| Total, serious adverse events | Dasatinib, 100 mg QD | 2 | 3 |
| Total, serious adverse events | Dasatinib, 140 mg QD | 1 | 4 |
| Total, serious adverse events | Dasatinib, 50 mg BID | 6 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00560352
GET https://conductscience.org/api/trials/v1/NCT00560352/results?page=2