Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Novartis

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Renal Insufficiency

Treatments: Drug: BHQ880; Drug: dexamethasone; Drug: BHQ880 Placebo; Drug: bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337752

CBHQ880A2203

2009-010875-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

BHQ880 + bortezomib and dexamethasone

Experimental group

Treatment:

Drug: bortezomib

Drug: dexamethasone

Drug: BHQ880

BHQ880 Placebo + bortezomib and dexamethasone

Placebo Comparator group

Treatment:

Drug: bortezomib

Drug: dexamethasone

Drug: BHQ880 Placebo