Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01302886
First received: January 26, 2011
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers [ Time Frame: Throughout the study until disease progression ] [ Designated as safety issue: No ]
  • Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BHQ880 Drug: BHQ880

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302886

Locations
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, Florida
H. Lee Moffitt Cancer Center/University of South Florida 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-Siteman Cancer Ctr 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
France
Novartis Investigative Site
LILLE Cedex, France, 59037
Germany
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Würzburg, Germany, 97080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01302886     History of Changes
Other Study ID Numbers: CBHQ880A2204, 2010-022029-13
Study First Received: January 26, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
High risk Smoldering multiple myeloma,
BHQ880,
MM

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014