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Completed

NCT Number: NCT01337752

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

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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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Kidney Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Valencia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of multiple myeloma
  • Life expectancy of more than 6 months in the absence of intervention
  • Must not have received previous or be receiving current antimyeloma therapies
  • Renal insufficiency
  • Recovered from the effects of any prior surgery or radiotherapy

Exclusion criteria

  • Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
  • Paget's disease of bone or uncorrected hyperparathyroidism
  • Impaired cardiac function
  • Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
  • Pregnant or nursing (lactating) women,
  • Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

BHQ880

Drug

BHQ880 Placebo

Drug

Intravenous infusion

bortezomib

Drug

intravenous injection

Dexamethasone

Drug

Oral

Primary outcomes

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

    Time to first SRE from randomization

Secondary outcomes

  1. safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone

    Time frame: From screening through month 17

    Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity

  2. Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib

    Time frame: 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).

  3. Evaluate the effect of BHQ880 on bone metabolism

    Time frame: At screening and at months 3, 6, 12, and 18

    • 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

  4. Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone.

    Time frame: From the first dose of study medication through month 17

    • The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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