Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

December 11, 2020 updated by: Novartis Pharmaceuticals

A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Spain
      • Madrid, Spain, 28006
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Novartis Investigative Site
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Novartis Investigative Site
      • Oxford, United Kingdom, OX3 7LJ
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Chicago Hospital Dept. of Univ of Chicago (2)
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates, PS

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Confirmed diagnosis of multiple myeloma
  2. Life expectancy of more than 6 months in the absence of intervention
  3. Must not have received previous or be receiving current antimyeloma therapies
  4. Renal insufficiency
  5. Recovered from the effects of any prior surgery or radiotherapy

Exclusion Criteria:

  1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
  2. Paget's disease of bone or uncorrected hyperparathyroidism
  3. Impaired cardiac function
  4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
  5. Pregnant or nursing (lactating) women,
  6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHQ880 + bortezomib and dexamethasone
Drug: BHQ880
Drug: bortezomib
intravenous injection
Drug: dexamethasone
Oral
Placebo Comparator: BHQ880 Placebo + bortezomib and dexamethasone
Drug: bortezomib
intravenous injection
Drug: dexamethasone
Oral
Drug: BHQ880 Placebo
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone
Time Frame: 18-month median time to first SRE assumed for the placebo arm
Time to first SRE from randomization
18-month median time to first SRE assumed for the placebo arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
Time Frame: From screening through month 17
Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity
From screening through month 17
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
Time Frame: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).
At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Evaluate the effect of BHQ880 on bone metabolism
Time Frame: At screening and at months 3, 6, 12, and 18
1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), from randomization to 12 and 18 months; 2) Change in bone strength, measured by quantitative computed tomography (qCT), from randomization to 3 and 6 months
At screening and at months 3, 6, 12, and 18
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
Time Frame: From the first dose of study medication through month 17
1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880
From the first dose of study medication through month 17

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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.

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBHQ880A2203
  • 2009-010875-26 (EudraCT Number)

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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