Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193557
• Other study ID #: SCRI MM 06
• Secondary ID: 208538
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 28, 2010
• Start date: May 2004
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

Description:

Upon determination of eligibility, patients will be receive:

• Bortezomib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Multiple Myeloma

• Received no more than 2 previous treatment regimens for multiple Myeloma

• ECOG performance status 0, 1, or 2

• Serum creatinine < 2.0mg/dL

• calculated or measured creatinine clearance > 30ml/minute

• Measurable or evaluable disease

• Provide written informed consent prior to receiving protocol therapy.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Moderate or severe peripheral neuropathy

• Other serious medical conditions

• Other active malignancies

• history of treatment for other invasive cancers

• Women who are pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib

Locations

Country	Name	City	State
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hainsworth JD, Spigel DR, Barton J, Farley C, Schreeder M, Hon J, Greco FA. Weekly treatment with bortezomib for patients with recurrent or refractory multiple myeloma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Aug 15;113(4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate
Secondary	progression-free survival
Secondary	overall survival
Secondary	Safety

External Links

•   Published article in the Journal of Clinical Oncology