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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01302886
Other study ID # CBHQ880A2204
Secondary ID 2010-022029-13
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2011
Est. completion date November 2013

Study information

Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma 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: 1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid 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. Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Intervention

Drug:
BHQ880


Locations

Country Name City State
France Novartis Investigative Site LILLE Cedex
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Würzburg
United States Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) Atlanta Georgia
United States Dana Farber Cancer Institute DFCI (2) Boston Massachusetts
United States Duke University Medical Center Duke SC Durham North Carolina
United States Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville Arkansas
United States Hackensack University Medical Center Multiple Myeloma Division Hackensack New Jersey
United States Indiana University Indiana Univ Indianapolis Indiana
United States Mount Sinai School of Medicine Mt Sinai New York New York
United States Washington University School of Medicine Dept. of WUSTL Saint Louis Missouri
United States Fred Hutchinson Cancer Research Center Fred Hutchinson Seattle Washington
United States H. Lee Moffitt Cancer Center & Research Institute SC - 3 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at 6 month
Secondary Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values From start of study until disease progression
Secondary Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma Throughout the study until disease progression
Secondary Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers Throughout the study until disease progression
Secondary Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT 6 months and 12 months
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