Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
NCT ID: NCT01302886
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2011-05-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BHQ880
BHQ880
Interventions
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BHQ880
Eligibility Criteria
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Inclusion Criteria
1. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
2. BMPC ≥ 10%, serum M-protein level \< 3 g/dL, and an abnormal free light chain ratio of \< 0.125 or \> 8.0
2. No previous or current anti-myeloma therapies
3. Patients ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Exclusion Criteria
2. Another primary malignant disease that requires systemic treatment
3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
5. Treatment with an investigational product within 28 days before the first dose of study treatment
6. Pregnant or nursing (lactating) women
7. Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Würzburg, , Germany
Countries
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Related Links
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Results for CBHQ880A2204 from the Novartis Clinical Trials website
Other Identifiers
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2010-022029-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBHQ880A2204
Identifier Type: -
Identifier Source: org_study_id
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