Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.

NCT01026701 | Completed DMC

• 3 other identifiers: CR01506726866138MMY4036BORKOR5020
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.

Conditions

Multiple Myeloma

Keywords

Osteoblst effect; Velcade; Proteasome inhibitor; Bortezomib; Multjple Myeloma

Outcome Measures

Primary Outcomes (1)

• bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)

  on day 1 at the first cycle, and 12-24 weeks

Secondary Outcomes (5)

• CR rate

  at the end of every 3 week cycle

• Overall response rate

  at the end of every 3 week cyclet

• Correlation between primary endpoints and response rate

  12 -24 weeks

• NRS pain score

  at the end of every 3 week cycle

• Adverse events

  at the end of every 3 week cycle

Study Arms (1)

001

bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

Drug: bortezomib

Interventions

bortezomib DRUG

injection into a vein 1.3 mg/m2 twice a week for 21 days

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included in Korea.

You may qualify if:

• Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included.

You may not qualify if:

• Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity
• Patients with severe hepatic impairment
• Women who are pregnant

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: March 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 28, 2014

Record last verified: 2014-04