Multiple Myeloma
Conditions
Brief summary
Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.
Interventions
BIOLOGICALACE-011
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
BIOLOGICALPlacebo
Placebo given by the subcutaneous route of administration monthly for 4 doses.
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patient at least 18 years of age with stage II or III multiple myeloma * One or more lytic bone lesions * If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1 * If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT * Has planned HSCT for the duration of the study * Has moles or lesions that are currently undiagnosed, but are suspect for malignancy * Has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate. Key
Exclusion criteria
* Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions * History of polyneuropathy ≥ grade 3 * Patients with plasma cell leukemia * Planned stem cell transplant (HSCT) or radiation for the duration of the study * Skeletal related event within 2 weeks of study enrollment * Has received erythropoiesis-stimulating agents (ESAs) within the last 21 days or is planned to receive ESAs during the course of the study * Has received anti-myeloma therapy within the last 21 days * Is scheduled to receive local radiation to bone during the course of the study * Has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment * Woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses. | 6 |
| 0.1 mg/kg ACE 011 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). | 8 |
| 0.3 mg/kg ACE 011 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169) | 8 |
| 0.5 mg/kg ACE 011 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169). | 8 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 1 |
| Overall Study | Investigator's request | 0 | 0 | 1 | 0 |
| Overall Study | Withdrew consent | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | 0.5 mg/kg ACE 011 | 0.3 mg/kg ACE 011 | 0.1 mg/kg ACE 011 |
|---|---|---|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 7.92 | 60.9 Years STANDARD_DEVIATION 10.42 | 57.8 Years STANDARD_DEVIATION 12.3 | 63.6 Years STANDARD_DEVIATION 7.5 | 60.5 Years STANDARD_DEVIATION 13.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 29 Participants | 8 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 15 Participants | 4 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 15 Participants | 4 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 8 | 0 / 8 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 7 / 8 | 7 / 8 | 8 / 8 | 4 / 6 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 | 3 / 8 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Hemoglobin
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.
Time frame: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
Population: All randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin | Day 8 | 0.47 g/dL | Standard Deviation 0.288 |
| Placebo | Change From Baseline in Hemoglobin | Day 113 | 0.33 g/dL | Standard Deviation 0.789 |
| Placebo | Change From Baseline in Hemoglobin | Day 85 | 0.78 g/dL | Standard Deviation 0.958 |
| Placebo | Change From Baseline in Hemoglobin | Day 29 | 0.50 g/dL | Standard Deviation 0.607 |
| Placebo | Change From Baseline in Hemoglobin | Day 169/Early Termination | 0.13 g/dL | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Hemoglobin | Day 36 | 1.02 g/dL | Standard Deviation 0.643 |
| Placebo | Change From Baseline in Hemoglobin | Day 57 | 0.53 g/dL | Standard Deviation 0.602 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 113 | 0.53 g/dL | Standard Deviation 1.141 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 57 | 0.47 g/dL | Standard Deviation 1.682 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 36 | 0.73 g/dL | Standard Deviation 1.873 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 85 | 0.57 g/dL | Standard Deviation 0.907 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 169/Early Termination | 0.57 g/dL | Standard Deviation 1.5 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 29 | -0.91 g/dL | Standard Deviation 1.844 |
| 0.1 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 8 | 0.89 g/dL | Standard Deviation 1.254 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 57 | 1.09 g/dL | Standard Deviation 1.022 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 8 | 0.83 g/dL | Standard Deviation 0.599 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 29 | 0.66 g/dL | Standard Deviation 0.457 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 36 | 1.00 g/dL | Standard Deviation 0.787 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 85 | 0.86 g/dL | Standard Deviation 1.323 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 113 | 0.96 g/dL | Standard Deviation 1.62 |
| 0.3 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 169/Early Termination | 0.33 g/dL | Standard Deviation 1.763 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 36 | 1.48 g/dL | Standard Deviation 1.167 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 169/Early Termination | 0.03 g/dL | Standard Deviation 2.392 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 113 | 0.97 g/dL | Standard Deviation 1.024 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 29 | 0.96 g/dL | Standard Deviation 1.648 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 8 | 0.80 g/dL | Standard Deviation 0.844 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 85 | 1.56 g/dL | Standard Deviation 0.704 |
| 0.5 mg/kg ACE 011 | Change From Baseline in Hemoglobin | Day 57 | 1.00 g/dL | Standard Deviation 1.22 |
Primary
Number of Participants With Electrocardiogram Abnormalities
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.
Time frame: Pre-dose, Day 1, Day 92, and Day 169
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Electrocardiogram Abnormalities | 4 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Electrocardiogram Abnormalities | 2 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Electrocardiogram Abnormalities | 2 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Electrocardiogram Abnormalities | 2 Participants |
Primary
Number of Participants With Hypertension or Increased Blood Pressure
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
Time frame: From baseline up to Day 92
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Hypertension or Increased Blood Pressure | 0 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Hypertension or Increased Blood Pressure | 1 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Hypertension or Increased Blood Pressure | 0 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Hypertension or Increased Blood Pressure | 2 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: From first dose up to termination visit on Day 169
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: From first dose to termination visit on Day 169
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 4 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 8 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
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.
Time frame: From first dose to termination visit on Day 169
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 0 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 1 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 0 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug | 1 Participants |
Secondary
Number of Participants With Skeletal-related Events (SRE)
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.
Time frame: From first dose up to 2 weeks post first dose
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Skeletal-related Events (SRE) | 0 Participants |
| 0.1 mg/kg ACE 011 | Number of Participants With Skeletal-related Events (SRE) | 1 Participants |
| 0.3 mg/kg ACE 011 | Number of Participants With Skeletal-related Events (SRE) | 2 Participants |
| 0.5 mg/kg ACE 011 | Number of Participants With Skeletal-related Events (SRE) | 2 Participants |
Secondary
Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
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.
Time frame: From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: All treated participants who had at least 1 postdosing measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 29 | -6.0 Percent change | Standard Deviation 12.25 |
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 57 | -7.2 Percent change | Standard Deviation 6.77 |
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 85 | -4.5 Percent change | Standard Deviation 3.78 |
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 113 | -3.5 Percent change | Standard Deviation 4.46 |
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 141 | 0.7 Percent change | Standard Deviation 13.05 |
| Placebo | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 169 | -3.0 Percent change | Standard Deviation 7.59 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 169 | -14.7 Percent change | Standard Deviation 24.59 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 113 | -13.7 Percent change | Standard Deviation 25.03 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 29 | -9.4 Percent change | Standard Deviation 22.6 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 85 | -12.7 Percent change | Standard Deviation 23.08 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 57 | -8.0 Percent change | Standard Deviation 26.09 |
| 0.1 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 141 | -13.7 Percent change | Standard Deviation 25.26 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 57 | -11.0 Percent change | Standard Deviation 33.87 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 85 | -10.5 Percent change | Standard Deviation 37.5 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 113 | -12.3 Percent change | Standard Deviation 38.04 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 169 | -15.0 Percent change | Standard Deviation 38.4 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 141 | -15.0 Percent change | Standard Deviation 37.33 |
| 0.3 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 29 | -5.8 Percent change | Standard Deviation 25.03 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 141 | -12.1 Percent change | Standard Deviation 32.79 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 169 | -13.6 Percent change | Standard Deviation 30.36 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 57 | -11.6 Percent change | Standard Deviation 26.34 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 113 | -11.4 Percent change | Standard Deviation 29.43 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 29 | -6.4 Percent change | Standard Deviation 23.87 |
| 0.5 mg/kg ACE 011 | Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) | Day 85 | -11.1 Percent change | Standard Deviation 28.79 |