Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Phase 2

Completed

• Conditions: Multiple Myeloma; Renal Insufficiency
• Interventions: Drug: BHQ880; Drug: BHQ880 Placebo; Drug: bortezomib; Drug: dexamethasone

• Registration Number: NCT01337752
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-19
• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BHQ880 + bortezomib and dexamethasone	BHQ880	-
BHQ880 + bortezomib and dexamethasone	bortezomib	-
BHQ880 + bortezomib and dexamethasone	dexamethasone	-
BHQ880 Placebo + bortezomib and dexamethasone	BHQ880 Placebo	-
BHQ880 Placebo + bortezomib and dexamethasone	bortezomib	-
BHQ880 Placebo + bortezomib and dexamethasone	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
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	18-month median time to first SRE assumed for the placebo arm	Time to first SRE from randomization

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone	From screening through month 17	Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity
Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib	At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34	Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).
Evaluate the effect of BHQ880 on bone metabolism	At screening and at months 3, 6, 12, and 18	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
Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.	From the first dose of study medication through month 17	1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880

Trial Locations

Locations (3)

Novartis Investigative Site; 🇬🇧 Southampton, United Kingdom

University Chicago Hospital Dept. of Univ of Chicago (2); 🇺🇸 Chicago, Illinois, United States

Medical Oncology Associates, PS; 🇺🇸 Spokane, Washington, United States