Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BHQ880 + bortezomib and dexamethasone

Group Type EXPERIMENTAL

BHQ880

Intervention Type DRUG

bortezomib

Intervention Type DRUG

intravenous injection

dexamethasone

Intervention Type DRUG

Oral

BHQ880 Placebo + bortezomib and dexamethasone

Group Type PLACEBO_COMPARATOR

BHQ880 Placebo

Intervention Type DRUG

Intravenous infusion

bortezomib

Intervention Type DRUG

intravenous injection

dexamethasone

Intervention Type DRUG

Oral

Interventions

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BHQ880

Intervention Type DRUG

BHQ880 Placebo

Intravenous infusion

Intervention Type DRUG

bortezomib

intravenous injection

Intervention Type DRUG

dexamethasone

Oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No