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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-01

Study Completion Date

2009-08-01

Brief Summary

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

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo given by the subcutaneous route of administration monthly for 4 doses.

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).

Group Type EXPERIMENTAL

ACE-011

Intervention Type BIOLOGICAL

ACE-011 given by the subcutaneous route of administration monthly for 4 doses.

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).

Group Type EXPERIMENTAL

ACE-011

Intervention Type BIOLOGICAL

ACE-011 given by the subcutaneous route of administration monthly for 4 doses.

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).

Group Type EXPERIMENTAL

ACE-011

Intervention Type BIOLOGICAL

ACE-011 given by the subcutaneous route of administration monthly for 4 doses.

Interventions

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ACE-011

ACE-011 given by the subcutaneous route of administration monthly for 4 doses.

Intervention Type BIOLOGICAL

Placebo

Placebo given by the subcutaneous route of administration monthly for 4 doses.

Intervention Type BIOLOGICAL

Other Intervention Names

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hActRIIA-IgG1

Eligibility Criteria

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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.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No