Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma|
- Clinical Response to Treatment [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria.
- Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher) [ Time Frame: 1-6 months ] [ Designated as safety issue: Yes ]Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).
- Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
- The Time to Response [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib and Thalidomide
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
Other Name: VELCADEDrug: thalidomide
- Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma.
- Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen.
- Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation.
- Determine the time to response in patients treated with this regimen.
- Assess the quality of life of patients treated with this regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287872
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Ivan Borrello, MD||Sidney Kimmel Comprehensive Cancer Center|