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An open‐label, phase 2 trial of denosumab in the treatment of relapsed or plateau‐phase multiple myeloma
American journal of hematology, 2009-10, Vol.84 (10), p.650-656
Vij, Ravi
Horvath, Noemi
Spencer, Andrew
Taylor, Kerry
Vadhan‐Raj, Saroj
Vescio, Robert
Smith, Judy
Qian, Yi
Yeh, Howard
Jun, Susie
2009
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Vij, Ravi
Horvath, Noemi
Spencer, Andrew
Taylor, Kerry
Vadhan‐Raj, Saroj
Vescio, Robert
Smith, Judy
Qian, Yi
Yeh, Howard
Jun, Susie
Titel
An open‐label, phase 2 trial of denosumab in the treatment of relapsed or plateau‐phase multiple myeloma
Ist Teil von
American journal of hematology, 2009-10, Vol.84 (10), p.650-656
Ort / Verlag
Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Erscheinungsjahr
2009
Quelle
Open access e-journals list
Beschreibungen/Notizen
RANKL is a key mediator of osteoclast differentiation, activation, and survival. Preclinical data suggest that aberrant production and activation of osteoclasts may influence proliferation of multiple myeloma (MM) cells in the bone marrow. Reports have also shown that inhibiting RANKL may have a direct effect on RANK‐expressing myeloma cells and a therapeutic role in treating the disease. In mouse myeloma models, inhibition of RANKL led to reduced serum paraprotein levels and tumor burden. Based on this hypothesis, this proof‐of‐concept, single‐arm study investigated whether RANKL inhibition with denosumab could reduce serum M‐protein levels in relapsed or plateau‐phase myeloma subjects. All subjects received denosumab monthly, with loading doses on days 8 and 15 of month one, until disease progression or subject discontinuation. Results of this ongoing study demonstrated that no subjects in either cohort met the protocol‐defined objective response criteria of complete response (CR) or partial response (PR), but that denosumab effectively inhibited the RANKL pathway regardless of previous exposure to bisphosphonates, as evidenced by suppressed levels of the bone turnover marker, serum C‐terminal telopeptide of type 1 collagen (sCTx). Eleven (21%) subjects who relapsed within 3 months before study entry maintained stable disease for up to 16.5 months. Nineteen (46%) subjects with plateau‐phase myeloma maintained stable disease for up to 18.3 months. The adverse event (AE) profile for denosumab and its dosing schedule in these populations was consistent with that for advanced cancer patients receiving systemic therapy. Additional controlled clinical studies of denosumab in subjects with both relapsed and plateau‐phase MM are warranted. Am. J. Hematol. 2009. © 2009 Wiley‐Liss, Inc.
Sprache
Englisch
Identifikatoren
ISSN: 0361-8609
eISSN: 1096-8652
DOI: 10.1002/ajh.21509
Titel-ID: cdi_proquest_miscellaneous_745631831
Format
–
Schlagworte
Antibodies, Monoclonal - administration & dosage
,
Antibodies, Monoclonal - adverse effects
,
Antibodies, Monoclonal - therapeutic use
,
Antibodies, Monoclonal, Humanized
,
Antineoplastic Agents - administration & dosage
,
Antineoplastic Agents - adverse effects
,
Antineoplastic Agents - therapeutic use
,
Australia
,
Biological and medical sciences
,
Bone Resorption - prevention & control
,
Cohort Studies
,
Denosumab
,
Disease-Free Survival
,
Drug Administration Schedule
,
Female
,
Hematologic and hematopoietic diseases
,
Humans
,
Immunodeficiencies. Immunoglobulinopathies
,
Immunoglobulinopathies
,
Immunoglobulins - blood
,
Immunopathology
,
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
,
Male
,
Medical sciences
,
Middle Aged
,
Multiple Myeloma - blood
,
Multiple Myeloma - drug therapy
,
Multiple Myeloma - metabolism
,
RANK Ligand - administration & dosage
,
RANK Ligand - adverse effects
,
RANK Ligand - therapeutic use
,
Recurrence
,
United States
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