A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Subcutaneous injection on days 1, 29, 57 and 85. |
Biological: Placebo
Placebo given by the subcutaneous route of administration monthly for 4 doses.
|
| Experimental: ACE-011 0.1 mg/kg Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
Biological: ACE-011
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
Other Names:
|
| Experimental: ACE-011 0.3 mg/kg Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
Biological: ACE-011
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
Other Names:
|
| Experimental: ACE-011 0.5 mg/kg Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). |
Biological: ACE-011
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Participants with Treatment-emergent Adverse Experiences [Up to Day 169]
- Change from baseline at end of treatment in Bone Specific Alkaline Phosphatase (BSAP) [Up to Day 169]
BSAP is a biomarker of bone formation.
- Change from baseline at end of treatment in Serum intact procollagen type I N terminal propeptide (PINP) [Up to Day 169]
PINP is a biomarker of bone formation.
- Change from Baseline at End of Treatment in Serum C-terminal type I collagen telopeptide (CTX) [Up to Day 169]
CTX is a bone resorption biomarker.
- Change from Baseline at End of Treatment in Serum tartrate-resistant acid phosphatase isoform-5b (Tracp-5b) [Up to Day 169]
Tracp-5b is a bone resorption biomarker.
Secondary Outcome Measures
- Change from Baseline at End of Treatment in Hip Bone Mineral Density [Up to Day 169]
- Change from Baseline at End of Treatment in Lumbar Spine Bone Mineral Density [Up to Day 169]
- Summary of Investigator's Bone Lesion Assessment Based on Skeletal X-rays During Follow-up [Up to Day 169]
- Change from Baseline to End of Treatment in Participant-reported Bone Pain Assessment Using a Visual Analog Scale (VAS) Score [Up to Day 169]
- Participants with Skeletal-related Adverse Events [Up to Day 169]
- Pharmacokinetics - AUC [Up to Day 169]
Area under the plasma concentration-time curve
- Pharmacokinetics - Cmax [Up to 169 days]
Maximum observed concentration
- Pharmacokinetics - Tmax [Up to 169 days]
Time to maximum observed concentration
- Pharmacokinetics - t½ [Up to 169 days]
Elimination half-life
- Pharmacokinetics - λz [Up to 169 days]
Elimination rate constant
- Pharmacokinetics - Vz/F [Up to 169 days]
Volume of distribution
- Pharmacokinetics - CL/F [Up to 169 days]
Total clearance
- Pharmacokinetics - Ka [Up to 169 days]
Absorption rate constant
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Site | Moscow | Russian Federation | ||
| 2 | Investigative Site | Saint-Petersburg | Russian Federation |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Abderrahmane Laadem, MD, Celgene Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
- A011-04