A Phase I Study of Samarium Sm-153 Lexidronam Combined With Bortezomib for Patients With Relapsed or Refractory Multiple Myeloma
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and dose-limiting toxicity
Yes
James R. Berenson, MD
Principal Investigator
Oncotherapeutics
United States: Food and Drug Administration
CDR0000479712
NCT00316940
December 2005
Name | Location |
---|---|
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 |