Trial Outcomes & Findings for Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT00719901)
NCT ID: NCT00719901
Last Updated: 2015-01-12
Results Overview
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.
TERMINATED
PHASE1/PHASE2
11 participants
Up to 21 days of every first course
2015-01-12
Participant Flow
Participants were recruited from 5 medical clinics in the United States between February 2008 and January 2011.
This was a phase I/II trial. A total of 11 participants were accrued, all to the phase I portion. 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.
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Alternate Treatment
|
1
|
|
Overall Study
Disease Progression
|
3
|
|
Overall Study
Availability of Study Drug
|
1
|
Baseline Characteristics
Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=10 Participants
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Performance Status
0=Fully active
|
1 participants
n=5 Participants
|
|
Performance Status
1=Restricted in physically strenuous activity
|
9 participants
n=5 Participants
|
|
Dose Level
Obatoclax mesylate IV 14 mg/m^2
|
3 participants
n=5 Participants
|
|
Dose Level
Obatoclax mesylate IV 30 mg/m^2
|
4 participants
n=5 Participants
|
|
Dose Level
Obatoclax mesylate IV 40 mg/m^2
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days of every first courseDLT 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.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=10 Participants
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)
|
4 Toxicity Incidents
|
PRIMARY outcome
Timeframe: From baseline to up to 3 yearsPopulation: No participants proceeded to Phase II for evaluation.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to up to 3 yearsIn 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.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=10 Participants
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients Who Have at Least a Partial Response (Phase I)
|
4 participants
|
SECONDARY outcome
Timeframe: Time from registration to the time of progressionPopulation: No participants proceeded to Phase II for evaluation.
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to death due to any causePopulation: No participants proceeded to Phase II for evaluation.
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from study entry to the date patients end treatmentPopulation: No participants proceeded to Phase II for evaluation.
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to up to 3 yearsPopulation: No participants proceeded to Phase II for evaluation.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=10 participants at risk
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Investigations
Neutrophil count decreased
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Depressed level of consciousness
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=10 participants at risk
Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
10/10 • Number of events 36
|
|
Cardiac disorders
Cardiac disorder
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Diplopia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
7/10 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 3
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
90.0%
9/10 • Number of events 27
|
|
Investigations
Lymphocyte count decreased
|
40.0%
4/10 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
80.0%
8/10 • Number of events 26
|
|
Investigations
Platelet count decreased
|
80.0%
8/10 • Number of events 23
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
4/10 • Number of events 10
|
|
Nervous system disorders
Ataxia
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 9
|
|
Nervous system disorders
Peripheral motor neuropathy
|
20.0%
2/10 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
70.0%
7/10 • Number of events 27
|
|
Nervous system disorders
Speech disorder
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Number of events 4
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 2
|
|
Psychiatric disorders
Euphoria
|
40.0%
4/10 • Number of events 6
|
|
Psychiatric disorders
Psychosis
|
30.0%
3/10 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
80.0%
8/10 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
20.0%
2/10 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60