Status:
COMPLETED
A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00747123
Start Date
September 1 2008
End Date
August 1 2009
Last Update
October 3 2024
Active Locations (2)
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1
Investigative Site
Moscow, Russia
2
Investigative Site
Saint Petersburg, Russia