Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
Primary Purpose
Smoldering Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BHQ880
Sponsored by
About this trial
This is an interventional treatment trial for Smoldering Multiple Myeloma focused on measuring High risk Smoldering multiple myeloma,, BHQ880,, MM
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
- BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
- BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
- No previous or current anti-myeloma therapies
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Exclusion Criteria:
- Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
- Another primary malignant disease that requires systemic treatment
- Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
- Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
- Treatment with an investigational product within 28 days before the first dose of study treatment
- Pregnant or nursing (lactating) women
- 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
Sites / Locations
- Highlands Oncology Group Dept of Highlands Oncology Grp
- H. Lee Moffitt Cancer Center & Research Institute SC - 3
- Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
- Indiana University Indiana Univ
- Dana Farber Cancer Institute DFCI (2)
- Washington University School of Medicine Dept. of WUSTL
- Hackensack University Medical Center Multiple Myeloma Division
- Mount Sinai School of Medicine Mt Sinai
- Duke University Medical Center Duke SC
- Fred Hutchinson Cancer Research Center Fred Hutchinson
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BHQ880
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Full Information
NCT ID
NCT01302886
First Posted
January 26, 2011
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01302886
Brief Title
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
Official Title
A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoldering Multiple Myeloma
Keywords
High risk Smoldering multiple myeloma,, BHQ880,, MM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BHQ880
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BHQ880
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Time Frame
Throughout the study until disease progression
Title
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
No previous or current anti-myeloma therapies
Patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Exclusion Criteria:
Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
Another primary malignant disease that requires systemic treatment
Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
Treatment with an investigational product within 28 days before the first dose of study treatment
Pregnant or nursing (lactating) women
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group Dept of Highlands Oncology Grp
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute SC - 3
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University Indiana Univ
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana Farber Cancer Institute DFCI (2)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine Dept. of WUSTL
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center Multiple Myeloma Division
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mount Sinai School of Medicine Mt Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center Duke SC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center Fred Hutchinson
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Novartis Investigative Site
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12765
Description
Results for CBHQ880A2204 from the Novartis Clinical Trials website
Learn more about this trial
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
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