An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma

American Journal of Hematology

Volumn 84, Issue 10, 2009, Pages 650-656

  Vij, Ravi ^a   Horvath, Noemi ^b   Spencer, Andrew ^c   Taylor, Kerry ^d   Vadhan Raj, Saroj ^e   Vescio, Robert ^f   Smith, Judy ^g   Qian, Yi ^g   Yeh, Howard ^g   Jun, Susie ^g  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ROYAL ADELAIDE HOSPITAL   (Australia)

^c ALFRED HOSPITAL   (Australia)

^d Haematology and Oncology Clinics of Australasia   (Australia)

^e UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^f CEDARS SINAI MEDICAL CENTER   (United States)

^g AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; BORTEZOMIB; CARBOXY TERMINAL TELOPEPTIDE; CORTICOSTEROID; DENOSUMAB; LENALIDOMIDE; M PROTEIN; OSTEOCLAST DIFFERENTIATION FACTOR; THALIDOMIDE;

ADULT; ADVANCED CANCER; ANEMIA; ARTICLE; BLOOD LEVEL; BONE TURNOVER; CANCER PATIENT; CANCER RELAPSE; CLINICAL PROTOCOL; CLINICAL TRIAL; DISEASE COURSE; DRUG INDUCED HEADACHE; DRUG RESPONSE; DYSPNEA; FATIGUE; FEMALE; GASTRITIS; HUMAN; HYPOCALCEMIA; HYPOPHOSPHATEMIA; JAW OSTEONECROSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTIPLE MYELOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; AUSTRALIA; BONE RESORPTION; COHORT STUDIES; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IMMUNOGLOBULINS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; RANK LIGAND; RECURRENCE; UNITED STATES;

EID: 70349488703     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.21509     Document Type: Article

References (28)

1. Ries LAG, Melbert D, Krapcho M, et al., editors. SEER Cancer Statistics Review, 1975-2005. Bethesda, MD: National Cancer Institute; 2007. Available at: http://seer.cancer.gov/csr/1975-2005/. Accessed on March 3, 2009.
2. Terpos E, Szydlo R, Apperley JF, et al. Soluble receptor activator of nuclear factor kappaB ligand-osteoprotegerin ratio predicts survival in multiple myeloma: Proposal for a novel prognostic index. Blood 2003;102:1064-1069. (Pubitemid 36917805)
3. Yaccoby S, Pearse RN, Johnson CL, et al. Myeloma interacts with the bone marrow microenvironment to induce osteoclastogenesis and is dependent on osteoclast activity. Br J Haematol 2002;116:278-290. (Pubitemid 34156975)
4. Pearse RN, Sordillo EM, Yaccoby S, et al. Multiple myeloma disrupts the TRANCE/osteoprotegerin cytokine axis to trigger bone destruction and promote tumor progression. Proc Natl Acad Sci USA 2001;98:11581-11586. (Pubitemid 32928771)
5. Yaccoby S, Wezeman MJ, Henderson A, et al. Cancer and the microenvironment: Myeloma-osteoclast interactions as a model. Cancer Res 2004;64:2016-2023. (Pubitemid 38339448)
6. Fuller K, Wong B, Fox S, et al. TRANCE is necessary and sufficient for osteoblast-mediated activation of bone resorption in osteoclasts. J Exp Med 1998;188:997-1001. (Pubitemid 28433427)
7. Lacey DL, Tan HL, Lu J, et al. Osteoprotegerin ligand modulates murine osteoclast survival in vitro and in vivo. Am J Pathol 2000;157:435-448. (Pubitemid 30626907)
8. Lacey DL, Timms E, Tan HL, et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 1998;93:165-176. (Pubitemid 28180851)
9. Roux S, Meignin V, Quillard J, et al. RANK (receptor activator of nuclear factor-kappaB) and RANKL expression in multiple myeloma. Br J Haematol 2002;117:86-92. (Pubitemid 34304425)
10. Giuliani N, Bataille R, Mancini C, et al. Myeloma cells induce imbalance in the osteoprotegerin/osteoprotegerin ligand system in the human bone marrow environment. Blood 2001;98:3527-3533.
11. Giuliani N, Colla S, Sala R, et al. Human myeloma cells stimulate the receptor activator of nuclear factor-B ligand (RANKL) in T lymphocytes: A potential role in multiple myeloma bone disease. Blood 2002;100:4615-4621. (Pubitemid 35429706)
12. Heider U, Langelotz C, Jakob C, et al. Expression of receptor activator of nuclear factor kappaB ligand on bone marrow plasma cells correlates with osteolytic bone disease in patients with multiple myeloma. Clin Cancer Res 2003;9:1436-1440. (Pubitemid 36418398)
13. Shaughnessy J, Barlogie B. Interpreting the molecular biology and clinical behavior of multiple myeloma in the context of global gene expression profiling. Immunol Rev 2003;194:140-163. (Pubitemid 36886434)
14. Body JJ, Greipp P, Coleman RE, et al. A phase I study of AMGN-0007, a recombinant osteoprotegerin construct, in patients with multiple myeloma or breast carcinoma related bone metastases. Cancer 2003;97: 887-892. (Pubitemid 36125828)
15. Croucher PI, Shipman CM, Lippitt J, et al. Osteoprotegerin inhibits the development of osteolytic bone disease in multiple myeloma. Blood 2001;98:3534-3540.
16. Vanderkerken K, De Leenheer E, Shipman C, et al. Recombinant osteoprotegerin decreases tumor burden and increases survival in a murine model of multiple myeloma. Cancer Res 2003;63:287-289. (Pubitemid 36152481)
17. Body J, Facon T, Coleman R, et al. A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer. Clin Cancer Res 2006;12:1221-1228. (Pubitemid 43342512)
18. Lipton A, Steger G, Figueroa J, et al. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer related bone metastases. J Clin Oncol 2007;25:4431-4437. (Pubitemid 350013849)
19. Brown J, Cook R, Major P, et al. Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst 2005;97:59-69.
20. Brown J, Thomson C, Ellis S, et al. Bone resorption predicts for skeletal complications in metastatic bone disease. Br J Cancer 2003;89:2031-2037. (Pubitemid 38030899)
21. Lipton A, Steger G, Figueroa J, et al. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res 2008;14:6690-6696.
22. Hazlehurst L, Landowski T, Dalton W. Role of the tumor microenvironment in mediating de novo resistance to drugs and physiological mediators of cell death. Oncogene 2003;22:7396-7402. (Pubitemid 37487165)
23. Nefedova Y, Landowski T, Dalton W. Bone marrow stromal-derived soluble factors and direct cell contact contribute to de novo drug resistance of myeloma cells by distinct mechanisms. Leukemia 2003;17:1175-1182. (Pubitemid 36722250)
24. Cleeland CS. The measurement of pain from metastatic bone disease: Capturing the patient's experience. Clin Cancer Res 2006;12:6236s-6242s.
25. Serlin RC, Mendoza TR, Nakamura Y, et al. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995;61:277-284.
26. Cella D, Tulsky D, Gray G, et al. The functional assessment of cancer therapy (FACT) scale: Development and validation of the general measure. J Clin Oncol 1993;11:570-579. (Pubitemid 23071057)
27. Brooks R. EuroQol: The current state of play. Health Policy 1996;37:53-72.
28. Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. New Jersey: Wiley; 1981.