Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00316940|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib Radiation: samarium Sm 153 lexidronam pentasodium||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Samarium Sm-153 Lexidronam Combined With Bortezomib for Patients With Relapsed or Refractory Multiple Myeloma|
|Study Start Date :||December 2005|
|Primary Completion Date :||June 2008|
|Study Completion Date :||February 2011|
U.S. FDA Resources
- Maximum tolerated dose and dose-limiting toxicity
- Response rate (complete, partial, and minimal response)
- Time to disease progression and time to response
- Progression-free and overall survival
- Antitumor effects
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316940
|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|