Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
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
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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:
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
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 June 18, 2013