A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma

Celgene

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Biological: Placebo; Biological: ACE-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747123

A011-04

Details and patient eligibility

About

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subcutaneous injection on days 1, 29, 57 and 85.

Treatment:

Biological: Placebo

ACE-011 0.1 mg/kg

Experimental group

Description:

Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).

Treatment:

Biological: ACE-011

ACE-011 0.3 mg/kg

Experimental group

Description:

Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).

Treatment:

Biological: ACE-011

ACE-011 0.5 mg/kg

Experimental group

Description:

Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).

Treatment:

Biological: ACE-011