Clinical trial NCT01302886: Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoldering Multiple Myeloma
Keywords: High risk Smoldering multiple myeloma,
BHQ880,
MM
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: at 6 month
Secondary outcomes:
measure: Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values
timeFrame: From start of study until disease progression
measure: Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma
timeFrame: Throughout the study until disease progression
measure: Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
timeFrame: Throughout the study until disease progression
measure: Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group Dept of Highlands Oncology Grp
state: Arkansas
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute SC - 3
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Indiana Univ
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute DFCI (2)
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine Dept. of WUSTL
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center Multiple Myeloma Division
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine Mt Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Duke SC
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center Fred Hutchinson
state: Washington
city: LILLE Cedex
country: France
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: