Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
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
2 other identifiers
interventional
41
3 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 17, 2020
February 1, 2017
2.5 years
January 26, 2011
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
6 months and 12 months
Study Arms (1)
BHQ880
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703, United States
H. Lee Moffitt Cancer Center & Research Institute SC - 3
Tampa, Florida, 33612, United States
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, 30322, United States
Indiana University Indiana Univ
Indianapolis, Indiana, 46202, United States
Dana Farber Cancer Institute DFCI (2)
Boston, Massachusetts, 02115, United States
Washington University School of Medicine Dept. of WUSTL
St Louis, Missouri, 63110, United States
Hackensack University Medical Center Multiple Myeloma Division
Hackensack, New Jersey, 07601, United States
Mount Sinai School of Medicine Mt Sinai
New York, New York, 10029, United States
Duke University Medical Center Duke SC
Durham, North Carolina, 27710, United States
Fred Hutchinson Cancer Research Center Fred Hutchinson
Seattle, Washington, 98109, United States
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2011
First Posted
February 24, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 17, 2020
Record last verified: 2017-02