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Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 26, 2011
Last updated: February 21, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Smoldering Multiple Myeloma Drug: BHQ880 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 [ Time Frame: at 6 month ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BHQ880 Drug: BHQ880


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01302886

United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute SC - 3
Tampa, Florida, United States, 33612
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Indiana Univ
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute DFCI (2)
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University School of Medicine Dept. of WUSTL
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center Multiple Myeloma Division
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai School of Medicine Mt Sinai
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center Duke SC
Durham, North Carolina, United States, 27710
United States, Washington
Fred Hutchinson Cancer Research Center Fred Hutchinson
Seattle, Washington, United States, 98109
Novartis Investigative Site
LILLE Cedex, France, 59037
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Würzburg, Germany, 97080
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01302886     History of Changes
Other Study ID Numbers: CBHQ880A2204
2010-022029-13 ( EudraCT Number )
Study First Received: January 26, 2011
Last Updated: February 21, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
High risk Smoldering multiple myeloma,

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017