Trial · NCT00429949
A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma
NCT00429949, Phase 2, Completed, Washington University School of Medicine; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma. Trials, record NCT00429949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma
- NCT number
- NCT00429949
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Relapsed, Refractory or Plateau Phase Multiple Myeloma
- Interventions
- Dasatinib
- First posted
- 2007-02-01
- Last updated
- 2014-08-29
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate [Complete Response (CR) and Partial Response (PR)] | Completion of treatment (median duration of therapy was 51 days) | CR requires all of the following: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR. * \< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytoma PR requires all of the following: * 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks. -Reduction in 24 hr urinary light chain excretion by either \> 90% or to \< 200 mg, maintained for a minimum of 6 weeks. * 50% reduction in the size of soft tissue plas |
| Secondary | Time to Response | Completion of treatment (median duration of therapy was 51 days) | Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response. |
| Secondary | Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Up to 30 days following end of treatment (median duration of therapy was 51 days) | Toxicities were graded using the NCI Common Toxicity Criteria v3.0. |
| Secondary | Duration of Response | Completion of treatment (median duration of therapy was 51 days) | Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met. |
| Secondary | Event-free Survival (EFS) for Participants With Plateau Phase Disease | Completion of treatment (median duration of therapy was 51 days) | EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected. |
| Secondary | Event-free Survival (EFS) for Participants With Relapsed Disease | Completion of treatment (median duration of therapy was 51 days) | EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected. |
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 | Response Rate [Complete Response (CR) and Partial Response (PR)] | Completion of treatment (median duration of therapy was 51 days) | participants | NUMBER | |
| SECONDARY | Time to Response | Completion of treatment (median duration of therapy was 51 days) | Only one patient achieved a partial response. | cycles | NUMBER |
| SECONDARY | Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Up to 30 days following end of treatment (median duration of therapy was 51 days) | participants | NUMBER | |
| SECONDARY | Duration of Response | Completion of treatment (median duration of therapy was 51 days) | Only one patient achieved a partial response. | cycles | NUMBER |
| SECONDARY | Event-free Survival (EFS) for Participants With Plateau Phase Disease | Completion of treatment (median duration of therapy was 51 days) | days | MEDIAN | |
| SECONDARY | Event-free Survival (EFS) for Participants With Relapsed Disease | Completion of treatment (median duration of therapy was 51 days) | days | MEDIAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate [Complete Response (CR) and Partial Response (PR)] | Dasatinib 70 mg BID | Complete response | 0 | 0.5 to 17.3 | participants |
| Response Rate [Complete Response (CR) and Partial Response (PR)] | Dasatinib 100 mg BID | Complete response | 0 | participants | |
| Response Rate [Complete Response (CR) and Partial Response (PR)] | Dasatinib 70 mg BID | Partial response | 0 | participants | |
| Response Rate [Complete Response (CR) and Partial Response (PR)] | Dasatinib 100 mg BID | Partial response | 1 | participants | |
| Time to Response | Dasatinib | 5 | cycles | ||
| Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Dasatinib | Grade III anemia | 5 | participants | |
| Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Dasatinib | Grade III neutropenia | 2 | participants | |
| Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Dasatinib | Grade III thrombocytopenia | 2 | participants | |
| Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Dasatinib | Grade IV thrombocytopenia | 3 | participants | |
| Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) | Dasatinib | Grade III epistaxis | 2 | participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 21 | |
| Overall Study | COMPLETED | Dasatinib | 21 | |
| Overall Study | NOT COMPLETED | Dasatinib | 0 |
Source ClinicalTrials.gov
Adverse events121
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 | Alkaline phosphatase | Investigations | Dasatinib | 2 | 21 | |
| other | Anorexia | Metabolism and nutrition disorders | Dasatinib | 7 | 21 | |
| other | Aphasia | Nervous system disorders | Dasatinib | 1 | 21 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dasatinib | 3 | 21 | |
| other | Ataxia | Nervous system disorders | Dasatinib | 2 | 21 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Dasatinib | 4 | 21 | |
| other | Bad dreams | Psychiatric disorders | Dasatinib | 1 | 21 | |
| other | Bone ache | Musculoskeletal and connective tissue disorders | Dasatinib | 1 | 21 | |
| other | Bruising | Injury, poisoning and procedural complications | Dasatinib | 1 | 21 | |
| other | Buttocks pain | Musculoskeletal and connective tissue disorders | Dasatinib | 1 | 21 |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 21 | 21 |
| Total, serious adverse events | Dasatinib | 6 | 21 |
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/NCT00429949
GET https://conductscience.org/api/trials/v1/NCT00429949/results?page=2