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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Participants with Treatment-emergent Adverse Experiences

Outcome Time Frame:

Up to Day 169

Safety Issue:

Yes

Principal Investigator

Abderrahmane Laadem, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

A011-04

NCT ID:

NCT00747123

Start Date:

September 2008

Completion Date:

August 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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