Trial · NCT00719901
Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT00719901, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2013-12-09
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma. Trials, record NCT00719901. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT00719901
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Interventions
- obatoclax mesylate, bortezomib, laboratory biomarker analysis
- First posted
- 2008-07-22
- Last updated
- 2015-01-12
- Results first posted
- 2013-12-09
- Limitations and caveats
- This trial was terminated due to slow accrual and the drug supply of Obatoclax during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose-limiting Toxicity (DLT) Incidents (Phase I) | Up to 21 days of every first course | DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading. |
| Primary | Proportion of Patients Who Achieve a Partial Response or Better. (Phase II) | From baseline to up to 3 years | In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations. |
| Secondary | Number of Patients Who Have at Least a Partial Response (Phase I) | From baseline to up to 3 years | In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations. |
| Secondary | Time to Progression (Phase II) | Time from registration to the time of progression | The distribution of time to progression will be estimated using the method of Kaplan-Meier. |
| Secondary | Overall Survival (Phase II) | Time from registration to death due to any cause | The distribution of overall survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Time to Treatment Failure (Phase II) | Time from study entry to the date patients end treatment | Time to treatment failure will be evaluated using the method of Kaplan-Meier. |
| Secondary | Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II) | From baseline to up to 3 years | Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either "unrelated or unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Dose-limiting Toxicity (DLT) Incidents (Phase I) | Up to 21 days of every first course | Toxicity Incidents | NUMBER | |
| PRIMARY | Proportion of Patients Who Achieve a Partial Response or Better. (Phase II) | From baseline to up to 3 years | No participants proceeded to Phase II for evaluation. | ||
| SECONDARY | Number of Patients Who Have at Least a Partial Response (Phase I) | From baseline to up to 3 years | participants | NUMBER | |
| SECONDARY | Time to Progression (Phase II) | Time from registration to the time of progression | No participants proceeded to Phase II for evaluation. | ||
| SECONDARY | Overall Survival (Phase II) | Time from registration to death due to any cause | No participants proceeded to Phase II for evaluation. | ||
| SECONDARY | Time to Treatment Failure (Phase II) | Time from study entry to the date patients end treatment | No participants proceeded to Phase II for evaluation. | ||
| SECONDARY | Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II) | From baseline to up to 3 years | No participants proceeded to Phase II for evaluation. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Dose-limiting Toxicity (DLT) Incidents (Phase I) | Treatment (Enzyme Inhibitor Therapy) | 4 | Toxicity Incidents | ||
| Number of Patients Who Have at Least a Partial Response (Phase I) | Treatment (Enzyme Inhibitor Therapy) | 4 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Enzyme Inhibitor Therapy) | 11 | |
| Overall Study | COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 11 |
Source ClinicalTrials.gov
Adverse events33
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Treatment (Enzyme Inhibitor Therapy) | 10 | 10 | 36 |
| other | Cardiac disorder | Cardiac disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 10 | 1 |
| other | Diplopia | Eye disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 10 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 2 | 10 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 7 | 10 | 12 |
| other | Nausea | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 4 | 10 | 7 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 2 | 10 | 3 |
| other | Fatigue | General disorders | Treatment (Enzyme Inhibitor Therapy) | 5 | 10 | 6 |
| other | Hypersensitivity | Immune system disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 10 | 1 |
| other | Leukocyte count decreased | Investigations | Treatment (Enzyme Inhibitor Therapy) | 9 | 10 | 27 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Enzyme Inhibitor Therapy) | ||
| Total, other adverse events | Treatment (Enzyme Inhibitor Therapy) | 10 | 10 |
| Total, serious adverse events | Treatment (Enzyme Inhibitor Therapy) | 3 | 10 |
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/NCT00719901
GET https://conductscience.org/api/trials/v1/NCT00719901/events?page=2