Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • LILLE Cedex, France, 59037
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Würzburg, Germany, 97080
        • Novartis Investigative Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group Dept of Highlands Oncology Grp
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute SC - 3
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Indiana Univ
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute DFCI (2)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Dept. of WUSTL
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Multiple Myeloma Division
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Mt Sinai
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Duke SC
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center Fred Hutchinson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHQ880

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From start of study until disease progression
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
Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers
Time Frame: Throughout the study until disease progression
Throughout the study until disease progression
Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT
Time Frame: 6 months and 12 months
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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