A Phase I Study of Samarium Sm-153 Lexidronam Combined With Bortezomib for Patients With Relapsed or Refractory Multiple Myeloma
- 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
- Assess the antitumor effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of samarium Sm 153 lexidronam
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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and dose-limiting toxicity
James R. Berenson, MD
United States: Food and Drug Administration
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Fountain Valley, California 92708|
|Hematology-Oncology Medical Group of Fresno, Incorporated||Fresno, California 93720|
|Center for Cancer and Blood Disorders at Suburban Hospital||Bethesda, Maryland 20817|