Clinical trial NCT01337752: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Renal Insufficiency
Keywords: multiple myeloma
renal insufficiency
untreated multiple myeloma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 9
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18-month median time to first SRE assumed for the placebo arm
Secondary outcomes:
measure: safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone
timeFrame: From screening through month 17
measure: Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib
timeFrame: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34
measure: Evaluate the effect of BHQ880 on bone metabolism
timeFrame: At screening and at months 3, 6, 12, and 18
measure: Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.
timeFrame: From the first dose of study medication through month 17
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Chicago Hospital Dept. of Univ of Chicago (2)
state: Illinois
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: