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Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Primary Purpose

Multiple Myeloma, Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BHQ880
BHQ880 Placebo
bortezomib
dexamethasone
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, renal insufficiency, untreated multiple myeloma

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Chicago Hospital Dept. of Univ of Chicago (2)
  • Medical Oncology Associates, PS
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BHQ880 + bortezomib and dexamethasone

BHQ880 Placebo + bortezomib and dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

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 to first SRE from randomization

Secondary Outcome Measures

safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).
Evaluate the effect of BHQ880 on bone metabolism
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
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880

Full Information

First Posted
April 12, 2011
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01337752
Brief Title
Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Renal Insufficiency
Keywords
multiple myeloma, renal insufficiency, untreated multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BHQ880 + bortezomib and dexamethasone
Arm Type
Experimental
Arm Title
BHQ880 Placebo + bortezomib and dexamethasone
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BHQ880
Intervention Type
Drug
Intervention Name(s)
BHQ880 Placebo
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
intravenous injection
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Oral
Primary Outcome Measure Information:
Title
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
Description
Time to first SRE from randomization
Time Frame
18-month median time to first SRE assumed for the placebo arm
Secondary Outcome Measure Information:
Title
safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
Description
Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity
Time Frame
From screening through month 17
Title
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
Description
Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).
Time Frame
At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Title
Evaluate the effect of BHQ880 on bone metabolism
Description
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
Time Frame
At screening and at months 3, 6, 12, and 18
Title
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
Description
1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880
Time Frame
From the first dose of study medication through month 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of multiple myeloma Life expectancy of more than 6 months in the absence of intervention Must not have received previous or be receiving current antimyeloma therapies Renal insufficiency Recovered from the effects of any prior surgery or radiotherapy Exclusion Criteria: Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry Paget's disease of bone or uncorrected hyperparathyroidism Impaired cardiac function Known HIV, known active hepatitis B, or known or suspected hepatitis C infection Pregnant or nursing (lactating) women, Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University Chicago Hospital Dept. of Univ of Chicago (2)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11143
Description
Results for CBHQ880A2203 from the Novartis Clinical Trials website

Learn more about this trial

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

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