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NCT01337752 Clinical Trial

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01337752
Other study ID # CBHQ880A2203
Secondary ID 2009-010875-26
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2012
Est. completion date May 2013

Study information
Verified date September 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• BHQ880

• BHQ880 Placebo
Intravenous infusion
• bortezomib
intravenous injection
• dexamethasone
Oral

Locations
Country Name City State
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Valencia Comunidad Valenciana
United Kingdom Novartis Investigative Site Bournemouth
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Oxford
United Kingdom Novartis Investigative Site Southampton
United States University Chicago Hospital Dept. of Univ of Chicago (2) Chicago Illinois
United States Medical Oncology Associates, PS Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 18-month median time to first SRE assumed for the placebo arm
Secondary 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 From screening through month 17
Secondary 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). At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
Secondary 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 At screening and at months 3, 6, 12, and 18
Secondary 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 From the first dose of study medication through month 17
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