Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive to radiation. Giving samarium 153 together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when given together with bortezomib in treating patients with relapsed or refractory multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Radiation: samarium Sm 153 lexidronam pentasodium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Samarium Sm-153 Lexidronam Combined With Bortezomib for Patients With Relapsed or Refractory Multiple Myeloma|
- Maximum tolerated dose and dose-limiting toxicity [ Designated as safety issue: Yes ]
- Response rate (complete, partial, and minimal response) [ Designated as safety issue: No ]
- Time to disease progression and time to response [ Designated as safety issue: No ]
- Progression-free and overall survival [ Designated as safety issue: No ]
- Antitumor effects [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- Assess the safety and tolerability (maximum tolerated dose and dose-limiting toxicity) of samarium Sm 153 lexidronam pentasodium and bortezomib in patients with relapsed or refractory multiple myeloma.
- Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
- Determine the time to response and the time to progression of disease in patients treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Assess the antitumor effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of samarium Sm 153 lexidronam pentasodium.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and samarium Sm 153 lexidronam pentasodium IV on day 3. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The MTD of samarium Sm 153 lexidronam pentasodium is determined with 2 different doses of bortezomib.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
|United States, California|
|Comprehensive Blood and Cancer Center|
|Bakersfield, California, United States, 93309-0633|
|Hematology-Oncology Medical Group of Fresno, Incorporated|
|Fresno, California, United States, 93720|
|West Hollywood, California, United States, 90069|
|United States, Maryland|
|Center for Cancer and Blood Disorders at Suburban Hospital|
|Bethesda, Maryland, United States, 20817|
|Principal Investigator:||James R. Berenson, MD||Oncotherapeutics|