Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Novartis Pharmaceuticals9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Myeloma Renal Insufficiency

Interventions

BHQ880DRUG

BHQ880 PlaceboDRUG

Intravenous infusion

bortezomibDRUG

intravenous injection

dexamethasoneDRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (8)

University Chicago Hospital Dept. of Univ of Chicago (2)

Chicago, Illinois, United States

Medical Oncology Associates, PS

Spokane, Washington, United States

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 18-month median time to first SRE assumed for the placebo arm

Secondary Outcomes

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

Time frame: From screening through month 17

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).

Time frame: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34

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

Time frame: 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.

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

Data from ClinicalTrials.gov

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