A Phase 2a, Multi-Center, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ACE-011 (hActRIIA-IgG1) in Patients With Osteolytic Lesions of Multiple Myeloma
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)