Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

NCT01337752 | Completed Phase 2

• 2 other identifiers: CBHQ880A22032009-010875-26
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 8

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.

Conditions

Multiple Myeloma; Renal Insufficiency

Keywords

multiple myeloma; renal insufficiency; untreated multiple myeloma

Outcome Measures

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 to first SRE from randomization

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

Secondary Outcomes (4)

• safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone

  From screening through month 17

• Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib

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

• Evaluate the effect of BHQ880 on bone metabolism

  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.

  From the first dose of study medication through month 17

Study Arms (2)

BHQ880 + bortezomib and dexamethasone

EXPERIMENTAL

Drug: BHQ880; Drug: bortezomib; Drug: dexamethasone

BHQ880 Placebo + bortezomib and dexamethasone

PLACEBO COMPARATOR

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

Interventions

BHQ880 DRUG

BHQ880 + bortezomib and dexamethasone

BHQ880 Placebo DRUG

Intravenous infusion

BHQ880 Placebo + bortezomib and dexamethasone

bortezomib DRUG

intravenous injection

BHQ880 + bortezomib and dexamethasone; BHQ880 Placebo + bortezomib and dexamethasone

dexamethasone DRUG

Oral

BHQ880 + bortezomib and dexamethasone; BHQ880 Placebo + bortezomib and dexamethasone

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

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

Chicago, Illinois, 60637, United States

Location

Medical Oncology Associates, PS

Spokane, Washington, 99208, United States

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Bournemouth, BH7 7DW, United Kingdom

Location

Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

Location

Novartis Investigative Site

Oxford, OX3 7LJ, United Kingdom

Location

Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Results for CBHQ880A2203 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Multiple Myeloma; Renal Insufficiency

Interventions

BHQ880; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 19, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 17, 2020

Record last verified: 2020-09

Locations

US (2); ES (2); GB (4)