Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Completed · Phase 2

Conditions studied: Smoldering Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01302886

Run by

Novartis Pharmaceuticals

People needed

41

Starts

2011-05-01

Expected to finish

2013-11-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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