Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
|First Received Date ICMJE||February 6, 2006|
|Last Updated Date||May 20, 2011|
|Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00287872 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma|
|Official Title ICMJE||VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma|
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.
NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.
Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Multiple Myeloma and Plasma Cell Neoplasm|
|Study Arm (s)||Not Provided|
|Publications *||Ghosh N, Ye X, Ferguson A, Huff CA, Borrello I. Bortezomib and thalidomide, a steroid free regimen in newly diagnosed patients with multiple myeloma. Br J Haematol. 2011 Mar;152(5):593-9. Epub 2011 Jan 17.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||35|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00287872|
|Other Study ID Numbers ICMJE||CDR0000450772, JHOC-J0456, JHOC-04063003, MILLENNIUM-JHOC-J0456|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Sidney Kimmel Comprehensive Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP