This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
H. Lee Moffitt Cancer Center & Research Institute SC - 3
Tampa, Florida, United States
Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A
Time frame: at 6 month
Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
Time frame: From start of study until disease progression
Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Time frame: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Time frame: Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Time frame: 6 months and 12 months
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Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, United States
Indiana University Indiana Univ
Indianapolis, Indiana, United States
Dana Farber Cancer Institute DFCI (2)
Boston, Massachusetts, United States
Washington University School of Medicine Dept. of WUSTL
St Louis, Missouri, United States
Hackensack University Medical Center Multiple Myeloma Division
Hackensack, New Jersey, United States
Mount Sinai School of Medicine Mt Sinai
New York, New York, United States
Duke University Medical Center Duke SC
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center Fred Hutchinson
Seattle, Washington, United States
...and 3 more locations