Trial · NCT00747123
A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
NCT00747123, Phase 2, Completed, Celgene; results first posted 2024-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma. Trials, record NCT00747123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00747123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
- NCT number
- NCT00747123
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Multiple Myeloma
- Interventions
- ACE-011, Placebo
- First posted
- 2008-09-04
- Last updated
- 2024-10-03
- Results first posted
- 2024-10-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose to termination visit on Day 169 | A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | From first dose to termination visit on Day 169 | A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | From first dose up to termination visit on Day 169 | A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported. |
| Primary | Change From Baseline in Hemoglobin | Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169 | Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement. |
| Primary | Number of Participants With Electrocardiogram Abnormalities | Pre-dose, Day 1, Day 92, and Day 169 | The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints. |
| Primary | Number of Participants With Hypertension or Increased Blood Pressure | From baseline up to Day 92 | The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as: * Systolic blood pressure ≤ 90 or ≥ 180 mmHg * Systolic blood pressure change (increase or decrease) ≥ 20 mmHg * Diastolic blood pressure ≤ 60 or ≥ 100 mmHg * Diastolic blood pressure change (increase or decrease) ≥ 15 mmHg |
| Secondary | Number of Participants With Skeletal-related Events (SRE) | From first dose up to 2 weeks post first dose | Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora. |
| Secondary | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose to termination visit on Day 169 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | From first dose to termination visit on Day 169 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | From first dose up to termination visit on Day 169 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hemoglobin | Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169 | All randomized participants | g/dL | MEAN |
| PRIMARY | Number of Participants With Electrocardiogram Abnormalities | Pre-dose, Day 1, Day 92, and Day 169 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hypertension or Increased Blood Pressure | From baseline up to Day 92 | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Skeletal-related Events (SRE) | From first dose up to 2 weeks post first dose | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | All treated participants who had at least 1 postdosing measurement | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Placebo | 4 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0.1 mg/kg ACE 011 | 7 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0.3 mg/kg ACE 011 | 7 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0.5 mg/kg ACE 011 | 8 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | Placebo | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 0.1 mg/kg ACE 011 | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 0.3 mg/kg ACE 011 | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 0.5 mg/kg ACE 011 | 1 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Placebo | 0 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | 0.1 mg/kg ACE 011 | 1 | Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | STARTED | 0.1 mg/kg ACE 011 | 8 | |
| Overall Study | STARTED | 0.3 mg/kg ACE 011 | 8 | |
| Overall Study | STARTED | 0.5 mg/kg ACE 011 | 8 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | COMPLETED | 0.1 mg/kg ACE 011 | 6 | |
| Overall Study | COMPLETED | 0.3 mg/kg ACE 011 | 7 | |
| Overall Study | COMPLETED | 0.5 mg/kg ACE 011 | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | 0.1 mg/kg ACE 011 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events180
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 | ACE 011 0.1 mg/kg | 1 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | ACE 011 0.3 mg/kg | 1 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | ACE 011 0.5 mg/kg | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 6 | |
| other | Eosinophilia | Blood and lymphatic system disorders | ACE 011 0.1 mg/kg | 0 | 8 | |
| other | Eosinophilia | Blood and lymphatic system disorders | ACE 011 0.3 mg/kg | 0 | 8 | |
| other | Eosinophilia | Blood and lymphatic system disorders | ACE 011 0.5 mg/kg | 0 | 8 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo | 1 | 6 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | ACE 011 0.1 mg/kg | 2 | 8 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | ACE 011 0.3 mg/kg | 1 | 8 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACE 011 0.1 mg/kg | 1 | 8 |
| Total, all-cause mortality | ACE 011 0.3 mg/kg | 0 | 8 |
| Total, all-cause mortality | ACE 011 0.5 mg/kg | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | ACE 011 0.1 mg/kg | 7 | 8 |
| Total, other adverse events | ACE 011 0.3 mg/kg | 7 | 8 |
| Total, other adverse events | ACE 011 0.5 mg/kg | 8 | 8 |
| Total, other adverse events | Placebo | 4 | 6 |
| Total, serious adverse events | ACE 011 0.1 mg/kg | 1 | 8 |
| Total, serious adverse events | ACE 011 0.3 mg/kg | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24650009 | BACKGROUND |
Source PubMed
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/NCT00747123
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