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Completed

NCT Number: NCT01302886

Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

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.

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Key information

Conditions

Smoldering Multiple Myeloma Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Neoplasms Paraproteinemias Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BHQ880

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers

    Time frame: Throughout the study until disease progression

  4. Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT

    Time frame: 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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