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A Phase I study of AMGN-0007, a recombinant osteoprotegerin construct, in patients with multiple myeloma or breast carcinoma related bone metastases
Open accessAbstract
BACKGROUND: Osteoprotegerin (OPG) is a decoy receptor for OPG ligand (OPGL), or receptor activator of NF-kappaB ligand (RANKL). RANKL/RANK interaction is important in terminal differentiation and activation of osteoclasts. In binding to RANKL, OPG blocks differentiation and activation of osteoclasts. AMGN-0007 is a recombinant OPG construct developed as a potential therapeutic agent in the treatment of bone disease. METHODS: A randomized, double-blind, double-dummy, active-controlled, single-dose, dose escalation study was conducted to determine the safety and effect on bone resorption of AMGN-0007 in patients with multiple myeloma (n = 28) or breast carcinoma (n = 26) with radiologically confirmed lytic bone lesions. Patients were randomized (3:1 ratio) to receive a single dose of either AMGN-0007 (subcutaneously [SC]) or pamidronate (90 mg intravenously) and were followed for 56 days. Medications or other diseases affecting bone metabolism and chemotherapy within 28 days of dosing were exclusion criteria. Biologic activity of AMGN-0007 was assessed by measurement of the surrogate marker of bone resorption, urinary N-telopeptide of collagen (NTX). RESULTS: AMGN-0007 caused a rapid, sustained, dose-dependent decrease in NTX/creatinine levels, which was at least comparable to the profile observed with pamidronate. Four serious adverse events were reported, three in breast carcinoma patients: a fracture in the left femur (pamidronate, considered unrelated), extreme fatigue (0.3 mg/kg AMGN-0007, considered unrelated), and congestive heart failure (1.0 mg/kg AMGN-0007, considered by the investigator to be probably related to doxorubicin and radiation therapy); one event occurred in a multiple myeloma patient: Herpes zoster (pamidronate, considered unrelated). Two multiple myeloma patients (1.0 mg/kg AMGN-0007) had albumin-adjusted serum calcium levels of 1.9 mmol/L on Day 8 but without clinical symptoms. CONCLUSIONS: A single SC dose of AMGN-0007 suppressed bone resorption as indicated by a rapid, sustained, and profound decrease of urinary NTX/creatinine in multiple myeloma and breast carcinoma patients. Changes were comparable to those with pamidronate. AMGN-0007 was well tolerated.
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“A dose-dependent reduction in uNTX occurred within 1 d of dosing with OPG-Fc, and uNTX reached a nadir of approximately Ϫ60 and Ϫ84% in the MM and breast cancer strata, respectively, at the higher doses (1.0 and 3.0 mg/kg).”
From Receptor Activator of Nuclear Factor κB Ligand and Osteoprotegerin Regulation of Bone Remodeling in Health and Disease (2008) · cites this paper as [23]
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“Suppression of bone resorption was maintained throughout the duration of the study (56 d).”
From Receptor Activator of Nuclear Factor κB Ligand and Osteoprotegerin Regulation of Bone Remodeling in Health and Disease (2008) · cites this paper as [23]
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“The pharmacodynamic profile of OPG-Fc was generally similar to that observed with the open-label active control, pamidronate.”
From Receptor Activator of Nuclear Factor κB Ligand and Osteoprotegerin Regulation of Bone Remodeling in Health and Disease (2008) · cites this paper as [23]
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Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation.
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Self-citationOsteoprotegerin: a novel secreted protein involved in the regulation of bone density.
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Self-citationHortobágyi, G. N., Theriault, R. L., Porter, L. L., Blayney, D. W., Lipton, A., Sinoff, C., Wheeler, H. T., Simeone, J. F., Seaman, J. J., Knight, R., et al. (1996) · New England Journal of Medicine · doi:10.1056/nejm199612123352401 · Cited by 1,024
Self-citationIsolation of a novel cytokine from human fibroblasts that specifically inhibits osteoclastogenesis.
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Research works printed but not linked: 2
- Caparelli, 2000, Cancer Res., 60, 783
- Morony, 2001, Cancer Res., 61, 4432
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Osteoclast differentiation and activation
Boyle, W. J., Simonet, W. S., & Lacey, D. L. (2003) · Nature · doi:10.1038/nature01658 · Cited by 6,670
Functions of RANKL/RANK/OPG in bone modeling and remodeling
Boyce, B. F., & Xing, L. (2008) · Archives of Biochemistry and Biophysics · doi:10.1016/j.abb.2008.03.018 · Cited by 1,844
Clinical Implications of the Osteoprotegerin/RANKL/RANK System for Bone and Vascular Diseases
Hofbauer, L. C. (2004) · JAMA · doi:10.1001/jama.292.4.490 · Cited by 990
Kearns, A. E., Khosla, S., & Kostenuik, P. J. (2008) · Endocrine Reviews · doi:10.1210/er.2007-0014 · Cited by 824
Bekker, P. J., Holloway, D. L., Rasmussen, A. S., Murphy, R., Martin, S. W., Leese, P. T., Holmes, G. B., Dunstan, C. R., & DePaoli, A. M. (2004) · Journal of Bone and Mineral Research · doi:10.1359/jbmr.040305 · Cited by 777
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Metadata
- Authors
- Body, J.-J., Greipp, P., Coleman, R. E., Facon, T., Geurs, F., Fermand, J.-P., Harousseau, J.-L., Lipton, A., Mariette, X., Williams, C. D., Nakanishi, A., Holloway, D., Martin, S. W., Dunstan, C. R., & Bekker, P. J.
- Affiliations
- Institut Jules Bordet (BE)
- Mayo Clinic (US)
- Weston Park Cancer Centre (GB)
- Centre Hospitalier Universitaire de Lille (FR)
- Hôpital Saint-Louis (FR)
- Penn State Milton S. Hershey Medical Center (US)
- The Christie Hospital (GB)
- Amgen (United States) (US)
- Corresponding author
- Bekker, Pirow J.
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2003-01-23
- Volume
- 97
- Issue
- S3
- Pages
- 887-892
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W1986310612
- Cited by
- 383
- References
- 18
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 1 · 2022: 7 · 2021: 6 · 2020: 7 · 2019: 9 · 2018: 8 · 2017: 14 · 2016: 7 · 2015: 12 · 2014: 17 · 2013: 19 · 2012: 17
- FWCI
- 17.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bone Metabolism and Diseases
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Keywords
- osteoprotegerin, RANKL, RANK, multiple myeloma, breast cancer, bone metastasis, osteolytic lesions, bone resorption, pamidronate, osteoclasts, drug safety, dose escalation, hypercalcemia, congestive heart failure, herpes zoster, phase I
- MeSH terms
- Pamidronate, Antineoplastic Agents, Bone Neoplasms, Bone Resorption, Breast Neoplasms, Diphosphonates, Dose-Response Relationship, Drug, Double-Blind Method, Female, Glycoproteins, Humans, Male, Middle Aged, Multiple Myeloma, Treatment Outcome, Receptors, Tumor Necrosis Factor, Receptors, Cytoplasmic and Nuclear, Osteoprotegerin
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