Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Smoldering Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302886
• Other study ID #: CBHQ880A2204
• Secondary ID: 2010-022029-13
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Smoldering Multiple Myeloma

Intervention

Drug:
• BHQ880

Locations

Country	Name	City	State
France	Novartis Investigative Site	LILLE Cedex
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Würzburg
United States	Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)	Atlanta	Georgia
United States	Dana Farber Cancer Institute DFCI (2)	Boston	Massachusetts
United States	Duke University Medical Center Duke SC	Durham	North Carolina
United States	Highlands Oncology Group Dept of Highlands Oncology Grp	Fayetteville	Arkansas
United States	Hackensack University Medical Center Multiple Myeloma Division	Hackensack	New Jersey
United States	Indiana University Indiana Univ	Indianapolis	Indiana
United States	Mount Sinai School of Medicine Mt Sinai	New York	New York
United States	Washington University School of Medicine Dept. of WUSTL	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center Fred Hutchinson	Seattle	Washington
United States	H. Lee Moffitt Cancer Center & Research Institute SC - 3	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma		Throughout the study until disease progression
Secondary	Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers		Throughout the study until disease progression
Secondary	Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT		6 months and 12 months

External Links

•   Results for CBHQ880A2204 from the Novartis Clinical Trials website