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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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